TM SCULPTO.R. REAMER SYSTEM

Sales Launch Manual

TABLE OF CONTENTS

Introduction ...... 1 I. Product Information ...... 2 II. Positioning ...... 9 III. Set Listings ...... 12 IV. Competition ...... 20 V. Cleaning Instructions ...... 25

©2000 Smith & Nephew, Inc. SculptO.R. is a trademark of Smith & Nephew, Inc. Pressure Sentinel is a trademark of Zimmer, Inc.Gray Intramedullary Flexible Reamer System is a trademark of Howmedica, Inc. INTRODUCTION

The SculptO.RTM Reamer System is Smith & Nephew’s newest innovation in instruments to complement the surgical tech- nique involved with IM Nailing. It offers surgeons the choice of instruments needed to follow either a reamed or unreamed technique.

REAMED SURGICAL TECHNIQUE Flexible reamers are used in the preparation of the medullary canal during interlocking nail or revision total hip replace- ment procedures. While reamers are used to enlarge the canal before a nail is implanted, it is also thought that reaming may increase bone healing by stimulating the osteo-blood supply. The decision of reaming vs unreaming is still being debated and remains the decision of the surgeon. For the reamed approach, a full selection of fixed and interchangeable reamers and flexible shafts are available as part of the SculptO.R. Reamer System.

UNREAMED SURGICAL TECHNIQUE Smith & Nephew is the only company that offers our customers Sounds to be used when following an unreamed surgical technique. Synthes, Howmedica, and Biomet do not include sounds in their reamer systems. Surgeons often use the inter- changeable reamer heads to sound the canal. This can cause problems due to the designs of the head and the potential for their sharp edges to become lodged in the intramedullary canal. Competitive sales representatives will often promote measuring for the nail diameter off the x-ray and nail gauges, since their systems do not include sounds.

Smith & Nephew offers a wide variety of nails that are designed to accommodate either a reamed or unreamed preference in surgical technique. For the unreamed approach, Sounds are used to measure the internal diameter of the canal by passing over a guide rod and across the isthmus. The largest diameter Sound which passes easiest through the isthmus signifies the correct nail diameter for implantation.

This launch booklet is designed to provide you with the key information needed to successfully sell the SculptO.R Reamer System to your customers. Reamer Systems are one of the few instruments still purchased by most hospitals because of their high frequency of use in orthopaedic procedures. The SculptO.R. Reamer System offers Smith & Nephew the unique opportunity to increase sales and support a variety of our products with this new line of instrumentation. Take time to read and absorb the important details provided within to improve the return on your sales investment!

TM SCULPTO.R. REAMER SYSTEM 1 KEY FEATURES AND BENEFITS

FEATURE BENEFIT LASER CUT SHAFT Cannulated tubing with a patented elliptical laser cut design for added strength, flexibility, and cleanability. Single wound design allows shaft to be reversed, minimizing unwinding and overload during reaming.

BULLET TIP DESIGN Designed to centralize the Reamer Head in the canal and minimize REAMER HEADS an eccentric reaming pattern.

DEEP CUTTING FLUTES Five cutting flutes oriented at a 15° helix angle designed to allow easier passage of bone chips around the reamer head to cut faster and cooler.

SMALL SHAFT DESIGN 7.6 mm diameter shaft designed to reduce intramedullary pressure.

SOUNDS A convenient option for customers who prefer unreamed techniques.

TM SCULPTO.R. REAMER SYSTEM 2 KEY PRODUCT FACTS

REAMER HEAD • Five cutting flutes

• 15° helix angle

• Interchangeable design for use with laser cut shaft

• Sizes 9.0 mm through 21.0 mm diameters in .5 mm increments

• Small bullet tip design

• Internal diameter of 3.2 mm must use the 3.0 mm Guide Rod (7111-8202)

• Dovetail connection

• 18.75” in length

TM SCULPTO.R. REAMER SYSTEM 3 KEY PRODUCT FACTS

FIXED REAMERS • Patented elliptical laser cut shaft design

• Reversible

• 5.4 mm shaft diameter

• Sizes available from 6.0 mm diameter through 11.0 mm diameter in .5 mm increments

• Internal diameter of 2.2 mm must use the 2.0 mm Guide Rod (7111-8201)

• Quick connection to power

TM SCULPTO.R. REAMER SYSTEM 4 KEY PRODUCT FACTS

FLEXIBLE SHAFT • Patented elliptical laser cut shaft design

• Dovetail connection

• ¼” distance between weld to reamer head connection

• Quick connect to power

• One size

• 7.6 mm diameter

• Reversible

• Internal diameter of 3.2 mm must use the 3.0 mm Guide Rod (7111-8202)

TM SCULPTO.R. REAMER SYSTEM 5 KEY PRODUCT FACTS

SOUNDS • Sizes 7 mm to 15 mm in 1.0 mm increments

• Determines canal diameter for appropriate selection of nail diameter

• Used for unreamed technique

• Optional tray

TM SCULPTO.R. REAMER SYSTEM 6 KEY PRODUCT FACTS

CASES • Optional sound case with sizes from 7 mm to 15 mm diameter in 1 mm increments

• Drops in bottom of reamer case

• Utilizes the new Smith & Nephew case design

• Two interchangeable shafts

• Reamer heads from 9.0 mm to 21.0 mm diameters in .5 mm increments

• Fixed 13.5 mm reamer

• Fixed reamers from 6.0 mm to 11.0 mm diameters in .5 mm increments

TM SCULPTO.R. REAMER SYSTEM 7 PRODUCT LISTING

PART NO. DESCRIPTION 7111-8200 SculptO.R. Flexible Shaft 7111-8260 Flexible Shaft for Old Reamer Heads 11-5128 Pseudoarthrosis Chisel 11-8165 5.0 mm T-handle Shaft Reamer 41-5330 Skin Protector 7111-8213 13.5 mm Fixed Reamer 7111-8212 T-handle Shaft 7111-8220 Fixed Reamer 6.0 mm 7111-8221 Fixed Reamer 6.5 mm 7111-8222 Fixed Reamer 7.0 mm 7111-8223 Fixed Reamer 7.5 mm 7111-8224 Fixed Reamer 8.0 mm 7111-8225 Fixed Reamer 8.5 mm 7111-8226 Fixed Reamer 9.0 mm 7111-8227 Fixed Reamer 9.5 mm 7111-8228 Fixed Reamer 10.0 mm 7111-8229 Fixed Reamer 10.5 mm 7111-8230 Fixed Reamer 11.0 mm 7111-8231 9.0 Reamer Head End Cutting 7111-8232 Reamer Head Pilot Nose, 9 mm 7111-8233 Reamer Head, 9.5 mm 7111-8234 Reamer Head, 10 mm 7111-8235 Reamer Head, 10.5 mm 7111-8236 Reamer Head, 11 mm 7111-8237 Reamer Head, 11.5 mm 7111-8238 Reamer Head, 12 mm 7111-8239 Reamer Head, 12.5 mm 7111-8240 Reamer Head, 13 mm 7111-8241 Reamer Head, 13.5 mm 7111-8242 Reamer Head, 14 mm 7111-8243 Reamer Head, 14.5 mm 7111-8244 Reamer Head, 15 mm 7111-8245 Reamer Head, 15.5 mm 7111-8246 Reamer Head, 16 mm 7111-8247 Reamer Head, 16.5 mm 7111-8248 Reamer Head, 17 mm 7111-8249 Reamer Head, 17.5 mm 7111-8250 Reamer Head, 18 mm 7111-8251 Reamer Head, 18.5 mm 7111-8252 Reamer Head, 19 mm 7111-8253 Reamer Head, 19.5 mm 7111-8254 Reamer Head, 20 mm 7111-8255 Reamer Head, 20.5 mm 7111-8256 Reamer Head, 21 mm 7111-8203 7.0 mm Sound 7111-8204 8.0 mm Sound 7111-8205 9.0 mm Sound 7111-8206 10.0 mm Sound 7111-8207 11.0 mm Sound 7111-8208 12.0 mm Sound 7111-8209 13.0 mm Sound 7111-8210 14.0 mm Sound 7111-8211 15.0 mm Sound 7111-8258 Sound Tray 7111-8257 Reamer Tray 7112-9401 2.4 Outer Case 7112-9402 2.4 Outer Case Lid

TM SCULPTO.R. REAMER SYSTEM 8 POSITIONING THE PRODUCT

PRODUCT POSITIONING STATEMENT: The SculptO.R. Flexible Reamer System is the most comprehensive product offering available, utilizing innovative designs to reduce temperature and pressure in the canal for improved surgical outcomes.

STRATEGIES FOR POSITIONING THE PRODUCT: • Upgrade existing accounts — A new laser cut shaft is also available to fit our existing reamer heads; item number 7111-8260. Customers who have recently purchased the Smith & Nephew’s older reamer system can upgrade their system, allowing them to utilize the new Flexible Reamer Shaft.

• Target new accounts by ordering one of the four-loaner sets available in Loaner Services to “show & tell” this new reamer system.

• Target competitive accounts that have experienced breakage or problems with competitive reamer systems.

• Target dissatisfied accounts that would like to upgrade their reamer system.

• Target high-volume orthopaedic accounts that are constantly having to replace reamer shafts.

• Target high volume nailing accounts that perform both reamed and unreamed procedures.

• Target trauma surgeons concerned with the heat and pressure build-up in the canal and those that have written papers, experienced necrosis and fat embolism after an IM nail procedure.

• Target small accounts that could benefit from having one system to use for both IM Nail Procedures and Revision Total Hip Procedures.

• Target orthopaedic surgeons who like aggressive cutting reamer heads.

• Target existing accounts that use and like Smith & Nephew Trauma products.

The above listing is a few examples of the type of surgeons and accounts to target with the new SculptO.R. Reamer System based on the key features and benefits it offers. Study the key features and benefits of the system to select your own account targets for the new system.

TM SCULPTO.R. REAMER SYSTEM 9 ACCOUNT TARGETING

Develop five account targets based on the Key Features and Benefits of the SculptO.R. Reamer System.

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TM SCULPTO.R. REAMER SYSTEM 10 ACCOUNT TARGETING

Develop five open-ended questions to use to target the SculptO.R. Reamer System to your surgeons or accounts.

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TM SCULPTO.R. REAMER SYSTEM 11 PRICING

The following customized pricing form has been developed to allow you to “customize” the set for your customer. This form will allow you to “pick and choose” which instruments your account will use in the system. Remember each account will be different, so “customize” the SculptO.R. Reamer System for your accounts.

TM SCULPTO.R. REAMER SYSTEM 12 SMITH &NEPHEW SCULPTO.R. REAMER SYSTEM

CUSTOMIZE PRICING ORDER FORM PART NO. PART DESCRIPTION TRANSFER PRICE QUANTITY ORDER PRICE 7111-8200 SculptO.R. Flexible Shaft (2 per case) 295.00 2 $ 590.00 7111-8260 Flexible Shaft for Old Reamer Heads 295.00 $ - 11-5128 Pseudoarthrosis Chisel 77.00 $ - 11-8165 5.0 mm T-handle Shaft Reamer 155.00 $ - 41-5330 Skin Protector 30.00 $ - 7111-8212 T-handle Shaft 340.00 $ - 7111-8213 13.5 mm Fixed Reamer 295.00 $ - 7111-8220 Fixed Reamer 6.0 mm 505.00 $ - 7111-8221 Fixed Reamer 6.5 mm 505.00 $ - 7111-8222 Fixed Reamer 7.0 mm 505.00 $ - 7111-8223 Fixed Reamer 7.5 mm 505.00 $ - 7111-8224 Fixed Reamer 8.0 mm 505.00 $ - 7111-8225 Fixed Reamer 8.5 mm 505.00 $ - 7111-8226 Fixed Reamer 9.0 mm 505.00 $ - 7111-8227 Fixed Reamer 9.5 mm 505.00 $ - 7111-8228 Fixed Reamer 10.0 mm 505.00 $ - 7111-8229 Fixed Reamer 10.5 mm 505.00 $ - 7111-8230 Fixed Reamer 11.0 mm 505.00 $ - 7111-8231 9.0 Reamer Head End Cutting 121.00 $ - 7111-8232 Reamer Head Pilot Nose, 9 mm 121.00 $ - 7111-8233 Reamer Head, 9.5 mm 121.00 $ - 7111-8234 Reamer Head, 10 mm 121.00 $ - 7111-8235 Reamer Head, 10.5 mm 121.00 $ - 7111-8236 Reamer Head, 11 mm 121.00 $ - 7111-8237 Reamer Head, 11.5 mm 121.00 $ - 7111-8238 Reamer Head, 12 mm 121.00 $ - 7111-8239 Reamer Head, 12.5 mm 121.00 $ - 7111-8240 Reamer Head, 13 mm 121.00 $ - 7111-8241 Reamer Head, 13.5 mm 121.00 $ - 7111-8242 Reamer Head, 14 mm 121.00 $ - 7111-8243 Reamer Head, 14.5 mm 121.00 $ - 7111-8244 Reamer Head, 15 mm 121.00 $ - 7111-8245 Reamer Head, 15.5 mm 121.00 $ - 7111-8246 Reamer Head, 16 mm 121.00 $ - 7111-8247 Reamer Head, 16.5 mm 121.00 $ - 7111-8248 Reamer Head, 17 mm 121.00 $ - 7111-8249 Reamer Head, 17.5 mm 121.00 $ - 7111-8250 Reamer Head, 18 mm 121.00 $ - 7111-8251 Reamer Head, 18.5 mm 121.00 $ - 7111-8252 Reamer Head, 19 mm 121.00 $ - 7111-8253 Reamer Head, 19.5 mm 121.00 $ - 7111-8254 Reamer Head, 20 mm 121.00 $ - 7111-8255 Reamer Head, 20.5 mm 121.00 $ - 7111-8256 Reamer Head, 21 mm 121.00 $ - 7111-8203 7.0 mm Sound 78.00 $ - 7111-8204 8.0 mm Sound 78.00 $ - 7111-8205 9.0 mm Sound 78.00 $ - 7111-8206 10.0 mm Sound 78.00 $ - 7111-8207 11.0 mm Sound 78.00 $ - 7111-8208 12.0 mm Sound 78.00 $ - 7111-8209 13.0 mm Sound 78.00 $ - 7111-8210 14.0 mm Sound 78.00 $ - 7111-8211 15.0 mm Sound 78.00 $ - 7111-8257 Reamer Tray 277.39 $ - 7111-8258 Sound Tray 130.00 $ - 7112-9401 2.4 Outer Case 210.48 $ - 7112-9402 2.4 Outer Case Lid 186.13 $ - TOTAL ***Pricing subject to change without prior notice

TM SCULPTO.R. REAMER SYSTEM 13 SET LISTINGS

IM NAIL REAMER SET WITH INTERCHANGEABLE HEADS UP TO 15.5 &W/OUT SOUNDS

SET NO. 7111-8305 PART NO. PART DESCRIPTION TRANSFER PRICE 7111-8200 Sculpt O.R. Flexible Shaft 295.00 7111-8200 Sculpt O.R. Flexible Shaft 295.00 115128 Pseudoarthrosis Chisel 77.00 118165 5.0 mm T-handle Shaft Reamer 155.00 415330 Skin Protector 30.00 7111-8212 T-handle Shaft 340.00 7111-8213 13.5 mm Fixed Reamer 295.00 7111-8220 Fixed Reamer 6.0 mm 505.00 7111-8221 Fixed Reamer 6.5 mm 505.00 7111-8222 Fixed Reamer 7.0 mm 505.00 7111-8223 Fixed Reamer 7.5 mm 505.00 7111-8224 Fixed Reamer 8.0 mm 505.00 7111-8225 Fixed Reamer 8.5 mm 505.00 7111-8226 Fixed Reamer 9.0 mm 505.00 7111-8227 Fixed Reamer 9.5 mm 505.00 7111-8228 Fixed Reamer 10.0 mm 505.00 7111-8229 Fixed Reamer 10.5 mm 505.00 7111-8230 Fixed Reamer 11.0 mm 505.00 7111-8231 9.0 Reamer Head End Cutting 121.00 7111-8232 Reamer Head Pilot Nose, 9 mm 121.00 7111-8233 Reamer Head, 9.5 mm 121.00 7111-8234 Reamer Head, 10 mm 121.00 7111-8235 Reamer Head, 10.5 mm 121.00 7111-8236 Reamer Head, 11 mm 121.00 7111-8237 Reamer Head, 11.5 mm 121.00 7111-8238 Reamer Head, 12 mm 121.00 7111-8239 Reamer Head, 12.5 mm 121.00 7111-8240 Reamer Head, 13 mm 121.00 7111-8241 Reamer Head, 13.5 mm 121.00 7111-8242 Reamer Head, 14 mm 121.00 7111-8243 Reamer Head, 14.5 mm 121.00 7111-8244 Reamer Head, 15 mm 121.00 7111-8245 Reamer Head, 15.5 mm 121.00 7111-8257 Reamer Tray 277.39 7112-9401 2.4 Outer Case 210.48 7112-9402 2.4 Outer Case Lid 186.13 TOTALS $9,531.00

TM SCULPTO.R. REAMER SYSTEM 14 SET LISTINGS

IM NAIL REAMER SET UP TO 15.5 INTERCHANGEABLE HEADS WITH SOUNDS

SET NO. 7111-8310 PART NO. PART DESCRIPTION TRANSFER PRICE 7111-8200 SculptO.R. Flexible Shaft 295.00 7111-8200 SculptO.R. Flexible Shaft 295.00 11-5128 Pseudoarthrosis Chisel 77.00 11-8165 5.0 mm T-handle Shaft Reamer 155.00 41-5330 Skin Protector 30.00 7111-8212 T-handle Shaft 340.00 7111-8213 13.5 mm Fixed Reamer 295.00 7111-8220 Fixed Reamer 6.0 mm 505.00 7111-8221 Fixed Reamer 6.5 mm 505.00 7111-8222 Fixed Reamer 7.0 mm 505.00 7111-8223 Fixed Reamer 7.5 mm 505.00 7111-8224 Fixed Reamer 8.0 mm 505.00 7111-8225 Fixed Reamer 8.5 mm 505.00 7111-8226 Fixed Reamer 9.0 mm 505.00 7111-8227 Fixed Reamer 9.5 mm 505.00 7111-8228 Fixed Reamer 10.0 mm 505.00 7111-8229 Fixed Reamer 10.5 mm 505.00 7111-8230 Fixed Reamer 11.0 mm 505.00 7111-8231 9.0 Reamer Head End Cutting 121.00 7111-8232 Reamer Head Pilot Nose, 9 mm 121.00 7111-8233 Reamer Head, 9.5 mm 121.00 7111-8234 Reamer Head, 10 mm 121.00 7111-8235 Reamer Head, 10.5 mm 121.00 7111-8236 Reamer Head, 11 mm 121.00 7111-8237 Reamer Head, 11.5 mm 121.00 7111-8238 Reamer Head, 12 mm 121.00 7111-8239 Reamer Head, 12.5 mm 121.00 7111-8240 Reamer Head, 13 mm 121.00 7111-8241 Reamer Head, 13.5 mm 121.00 7111-8242 Reamer Head, 14 mm 121.00 7111-8243 Reamer Head, 14.5 mm 121.00 7111-8244 Reamer Head, 15 mm 121.00 7111-8245 Reamer Head, 15.5 mm 121.00 7111-8246 7.0 mm Sound 78.00 7111-8204 8.0 mm Sound 78.00 7111-8205 9.0 mm Sound 78.00 7111-8206 10.0 mm Sound 78.00 7111-8207 11.0 mm Sound 78.00 7111-8208 12.0 mm Sound 78.00 7111-8209 13.0 mm Sound 78.00 7111-8210 14.0 mm Sound 78.00 7111-8211 15.0 mm Sound 78.00 7111-8257 Reamer Tray 277.39 7111-8258 Sound Tray 130.00 7112-9401 2.4 Outer Case 210.48 7112-9402 2.4 Outer Case Lid 186.13 TOTALS $10,363.00

TM SCULPTO.R. REAMER SYSTEM 15 SET LISTINGS

COMPLETE REAMER SET WITHOUT FIXED REAMERS

SET NO. 7111-8315 PART NO. PART DESCRIPTION TRANSFER PRICE 7111-8200 SculptO.R. Flexible Shaft 600.00 7111-8200 SculptO.R. Flexible Shaft 600.00 11-5128 Pseudoarthrosis Chisel 135.00 11-8165 5.0 mm T-handle Shaft Reamer 288.00 41-5330 Skin Protector 83.10 7111-8212 T-handle Shaft 725.00 7111-8213 13.5 mm Fixed Reamer 296.00 7111-8231 9.0 Reamer Head End Cutting 325.00 7111-8232 Reamer Head Pilot Nose, 9 mm 325.00 7111-8233 Reamer Head, 9.5 mm 325.00 7111-8234 Reamer Head, 10 mm 325.00 7111-8235 Reamer Head, 10.5 mm 325.00 7111-8236 Reamer Head, 11 mm 325.00 7111-8237 Reamer Head, 11.5 mm 325.00 7111-8238 Reamer Head, 12 mm 325.00 7111-8239 Reamer Head, 12.5 mm 325.00 7111-8240 Reamer Head, 13 mm 325.00 7111-8241 Reamer Head, 13.5 mm 325.00 7111-8242 Reamer Head, 14 mm 325.00 7111-8243 Reamer Head, 14.5 mm 325.00 7111-8244 Reamer Head, 15 mm 325.00 7111-8245 Reamer Head, 15.5 mm 325.00 7111-8246 Reamer Head, 16 mm 325.00 7111-8247 Reamer Head, 16.5 mm 325.00 7111-8248 Reamer Head, 17 mm 325.00 7111-8249 Reamer Head, 17.5 mm 325.00 7111-8250 Reamer Head, 18 mm 325.00 7111-8251 Reamer Head, 18.5 mm 325.00 7111-8252 Reamer Head, 19 mm 325.00 7111-8253 Reamer Head, 19.5 mm 325.00 7111-8254 Reamer Head, 20 mm 325.00 7111-8255 Reamer Head, 20.5 mm 325.00 7111-8256 Reamer Head, 21 mm 325.00 7111-8203 7.0 mm Sound 215.00 7111-8204 8.0 mm Sound 215.00 7111-8205 9.0 mm Sound 215.00 7111-8206 10.0 mm Sound 215.00 7111-8207 11.0 mm Sound 215.00 7111-8208 12.0 mm Sound 215.00 7111-8209 13.0 mm Sound 215.00 7111-8210 14.0 mm Sound 215.00 7111-8211 15.0 mm Sound 215.00 7111-8257 Reamer Tray 274.33 7111-8258 Sound Tray 133.00 7112-9401 2.4 Outer Case 432.67 71129402 2.4 Outer Case Lid 347.90 TOTALS $14,300.00

TM SCULPTO.R. REAMER SYSTEM 16 SET LISTINGS

COMPLETE REAMER SET WITHOUT SOUNDS

SET NO. 7111-8320 PART NO. PART DESCRIPTION TRANSFER PRICE 7111-8200 SculptO.R. Flexible Shaft 295.00 7111-8200 SculptO.R. Flexible Shaft 295.00 11-5128 Pseudoarthrosis Chisel 77.00 11-8165 5.0 mm T-handle Shaft Reamer 155.00 41-5330 Skin Protector 30.00 7111-8212 T-handle Shaft 340.00 7111-8213 13.5 mm Fixed Reamer 295.00 7111-8220 Fixed Reamer 6.0 mm 505.00 7111-8221 Fixed Reamer 6.5 mm 505.00 7111-8222 Fixed Reamer 7.0 mm 505.00 7111-8223 Fixed Reamer 7.5 mm 505.00 7111-8224 Fixed Reamer 8.0 mm 505.00 7111-8225 Fixed Reamer 8.5 mm 505.00 7111-8226 Fixed Reamer 9.0 mm 505.00 7111-8227 Fixed Reamer 9.5 mm 505.00 7111-8228 Fixed Reamer 10.0 mm 505.00 7111-8229 Fixed Reamer 10.5 mm 505.00 7111-8230 Fixed Reamer 11.0 mm 505.00 7111-8231 9.0 Reamer Head End Cutting 121.00 7111-8232 Reamer Head Pilot Nose, 9 mm 121.00 7111-8233 Reamer Head, 9.5 mm 121.00 7111-8234 Reamer Head, 10 mm 121.00 7111-8235 Reamer Head, 10.5 mm 121.00 7111-8236 Reamer Head, 11 mm 121.00 7111-8237 Reamer Head, 11.5 mm 121.00 7111-8238 Reamer Head, 12 mm 121.00 7111-8239 Reamer Head, 12.5 mm 121.00 7111-8240 Reamer Head, 13 mm 121.00 7111-8241 Reamer Head, 13.5 mm 121.00 7111-8242 Reamer Head, 14 mm 121.00 7111-8243 Reamer Head, 14.5 mm 121.00 7111-8244 Reamer Head, 15 mm 121.00 7111-8245 Reamer Head, 15.5 mm 121.00 7111-8246 Reamer Head, 16 mm 121.00 7111-8247 Reamer Head, 16.5 mm 121.00 7111-8248 Reamer Head, 17 mm 121.00 7111-8249 Reamer Head, 17.5 mm 121.00 7111-8250 Reamer Head, 18 mm 121.00 7111-8251 Reamer Head, 18.5 mm 121.00 7111-8252 Reamer Head, 19 mm 121.00 7111-8253 Reamer Head, 19.5 mm 121.00 7111-8254 Reamer Head, 20 mm 121.00 7111-8255 Reamer Head, 20.5 mm 121.00 7111-8256 Reamer Head, 21 mm 121.00 7111-8257 Reamer Tray 277.39 7112-9401 2.4 Outer Case 210.48 7112-9402 2.4 Outer Case Lid 186.13 TOTALS $10,862.00

TM SCULPTO.R. REAMER SYSTEM 17 SET LISTINGS

SOUNDS ONLY

SET NO. 7111-8325 PART NO. PART DESCRIPTION TRANSFER PRICE 7111-8212 T-handle Shaft 340.00 7111-8204 7.0 mm Sound 78.00 7111-8205 8.0 mm Sound 78.00 7111-8206 9.0 mm Sound 78.00 7111-8207 10.0 mm Sound 78.00 7111-8208 11.0 mm Sound 78.00 7111-8209 12.0 mm Sound 78.00 7111-8209 13.0 mm Sound 78.00 7111-8210 14.0 mm Sound 78.00 7111-8211 15.0 mm Sound 78.00 7111-8258 Sound Tray 130.00 TOTALS $1,172.00

TM SCULPTO.R. REAMER SYSTEM 18 SET LISTINGS

COMPLETE REAMER SET

SET NO. 7111-8330 PART NO. PART DESCRIPTION TRANSFER PRICE 7111-8200 SculptO.R. Flexible Shaft 295.00 7111-8200 SculptO.R. Flexible Shaft 295.00 11-5128 Pseudoarthrosis Chisel 77.00 11-8165 5.0 mm T-handle Shaft Reamer 155.00 41-5330 Skin Protector 30.00 7111-8212 T-handle Shaft 340.00 7111-8213 13.5 mm Fixed Reamer 295.00 7111-8220 Fixed Reamer 6.0 mm 505.00 7111-8221 Fixed Reamer 6.5 mm 505.00 7111-8222 Fixed Reamer 7.0 mm 505.00 7111-8223 Fixed Reamer 7.5 mm 505.00 7111-8224 Fixed Reamer 8.0 mm 505.00 7111-8225 Fixed Reamer 8.5 mm 505.00 7111-8226 Fixed Reamer 9.0 mm 505.00 7111-8227 Fixed Reamer 9.5 mm 505.00 7111-8228 Fixed Reamer 10.0 mm 505.00 7111-8229 Fixed Reamer 10.5 mm 505.00 7111-8230 Fixed Reamer 11.0 mm 505.00 7111-8231 9.0 Reamer Head End Cutting 121.00 7111-8232 Reamer Head Pilot Nose, 9 mm 121.00 7111-8233 Reamer Head, 9.5 mm 121.00 7111-8234 Reamer Head, 10 mm 121.00 7111-8235 Reamer Head, 10.5 mm 121.00 7111-8236 Reamer Head, 11 mm 121.00 7111-8237 Reamer Head, 11.5 mm 121.00 7111-8238 Reamer Head, 12 mm 121.00 7111-8239 Reamer Head, 12.5 mm 121.00 7111-8240 Reamer Head, 13 mm 121.00 7111-8241 Reamer Head, 13.5 mm 121.00 7111-8242 Reamer Head, 14 mm 121.00 7111-8243 Reamer Head, 14.5 mm 121.00 7111-8244 Reamer Head, 15 mm 121.00 7111-8245 Reamer Head, 15.5 mm 121.00 7111-8246 Reamer Head, 16 mm 121.00 7111-8247 Reamer Head, 16.5 mm 121.00 7111-8248 Reamer Head, 17 mm 121.00 7111-8249 Reamer Head, 17.5 mm 121.00 7111-8250 Reamer Head, 18 mm 121.00 7111-8251 Reamer Head, 18.5 mm 121.00 7111-8252 Reamer Head, 19 mm 121.00 7111-8253 Reamer Head, 19.5 mm 121.00 7111-8254 Reamer Head, 20 mm 121.00 7111-8255 Reamer Head, 20.5 mm 121.00 7111-8256 Reamer Head, 21 mm 121.00 7111-8203 7.0 mm Sound 78.00 7111-8204 8.0 mm Sound 78.00 7111-8205 9.0 mm Sound 78.00 7111-8206 10.0 mm Sound 78.00 7111-8207 11.0 mm Sound 78.00 7111-8208 12.0 mm Sound 78.00 7111-8209 13.0 mm Sound 78.00 7111-8210 14.0 mm Sound 78.00 7111-8211 15.0 mm Sound 78.00 7111-8257 Reamer Tray 277.39 7111-8258 Sound Tray 130.00 7112-9401 2.4 Outer Case 210.48 7112-9402 2.4 Outer Case Lid 186.13 TOTALS $11,694.00

TM SCULPTO.R. REAMER SYSTEM 19 COMPETITION

COMPETITIVE PROFILE The worldwide Reamer and Sound market constitutes approximately $5.1 million in sales. Reamers make up approxi- mately 9% of Smith & Nephew Instrument sales. While instruments are usually given away, reamers instrument sets are still often purchased by hospitals because of their frequency in use for various orthopaedic procedures.

CROSS REFERENCE CHART

Company Interchangeable Sounds Shaft Reamer Reamer Sound Guide Reamers Type Design Sizes Sizes Rod New SNO Yes Yes Laser Cut Oval w/ 6.0-11.0 7.0-15.0 2.0 mm, 3.0 mm Dovetail 6.0-21.0 Old SNO Yes Yes Wound Pilot 6.0-9.0 7.0-12.0 2.7 mm, 3.2 mm Dovetail Nose 6.0-21.0 Synthes Yes No Wire Square 7.0-9.0, NA 3.0 mm Coil w/Dovetail 9.5-19.0 Howmedica Yes No Wound Tear Drop 8.0-22.0 NA 3.0 mm w/Dovetail Zimmer Yes No Solid Tube Tear Drop 5.0-22.0 NA Biomet Yes No Wire Whip Barrel 8.0-20.5 NA 3.2 mm

COMPETITIVE PRICING

COMPETITIVE COMPARISON DOMESTIC S&N Current Reamer $10,829.00 Zimmer New System $17,500.00 Zimmer Intracone $ 6,856.00 Zimmer Modular $ 6,500.00 Howmedica Gray $19,508.00 Synthes $ 4,496.00 Biomet Medullary $ 7,420.00 Biomet Flex Wire $ 9,080.00 Average of all competitors $18,558.67

TM SCULPTO.R. REAMER SYSTEM 20 COMPETITION

SYNTHES ~ REAMING INSTRUMENTS Synthes is the second most prominent flexible reamer competitor due, in part, to their good reputation for trauma and their aggressive moves on the IM Nail market in recent years. Although Synthes promotes their nailing systems as “unreamed” implants, they offer reaming instruments up to 19.0 mm in the Interchangeable reamer heads. While their system is widely used, it has come under scrutiny recently, as studies have shown that their reamer design may contribute to high intramedullary pressures induced during reaming. Synthes reamers have not been updated and systems maybe dull from extensive use.

Synthes flexible shafts are available in two diameters (8 mm and 10 mm) and are available in 360 mm and 440 mm in length. The system includes a 7, 8, and 9 mm front cutting head reamer and 8 mm and 10 mm interchangeable shafts that apply to a 10.0–19.0 mm head size range used over a 3.0 mm guide rod x 950 mm. The shafts are made from three coaxially arranged tubular wire coils. Reversing of shafts with power is not recommended in the Synthes literature. The shafts are very flexible, however this advantage makes the shaft more at risk for unwinding.

Synthes’ reamer heads are attached to the shafts with a dovetail connection. The system includes reamer heads, shafts, a soft tissue protector, small and large awls, 3.0 mm reaming rods (1100 and 1250 mm lengths), a hollow chisel, meas- uring gauge, holding forceps, air jet and tube, single piece smaller hand reamers 5.0–11.0 mm, 11 mm Cannulated cutter, a quick coupling and handle with Jacob’s chuck connector, and a 4.0 mm x 400 mm centering pin.

FEATURES & BENEFITS TO SELL AGAINST SYNTHES • In static failure testing, Synthes 8 mm shaft failed at 139.2 inch pounds (at ultimate failure) in comparison to the SculptO.R. laser cut shaft at 243.3 inch pounds (almost 8 times the static strength).

• In static failure testing the Synthes 7.0 mm Fixed shaft (6 mm shaft ) failed at 23.5 inch pounds in comparison to the SculptO.R. 7.0 mm Fixed shaft at 7.8 inch pounds.

• ReversibleSculptO.R. laser cut shaft, while Synthes literature recommends not to run shaft in reverse mode.

• Synthes’ studies show smaller shaft reduces pressure and temperature. The SculptO.R. shaft is 7.5 mm diameter.

• The SculptO.R. system has interchangeable sizes available up to 21.0 mm for IM Nail and Total Hip procedures.

• Recent study criticizes the Synthes reamer design may contribute to high intramedullary pressures induced during reaming. (Reference: “Influence of the Reamer Shape on Intraosseus Pressure during Closed Intramedullary Nailing of the Unbroken Femur.”)

TM SCULPTO.R. REAMER SYSTEM 21 COMPETITION

HOWMEDICA ~ GRAY INTRAMEDULLARY FLEXIBLE REAMER SYSTEMTM Howmedica offers three reamer systems the Gray Intramedullary Reamer system, XR Acetabular Reamer System and the Rigid Reamer System. The Gray Intramedullary Reamer System is used in IM Nail procedures, and contains flexible shafts with interchangeable heads. The Gray Intramedullary Reamer System is sold by Howmedica in the U.S. and Europe. It has a unique helix shaped head which touts a sharper, cooler cut than traditional head designs. The head is also said to reduce jamming of the reamer in the canal. The “exclusive locking mechanism” is a dovetail design similar to those used by other companies, including Smith & Nephew. Heads are available from 8.0 mm to 22.0 mm and four shafts are avail- able: 7.5 mm x 420 mm, 7.5 mm x 240 mm, 8.5 mm x 420 mm, and 8.5 mm x 240 mm. Other items in the system include a Hall/Jacobs adapter, a grommet inserter/extractor and grommets, a Hudson power adapter, and case. The reamers run over 3.0 mm or 3.2 mm guide rods by 1000 mm in length.

Howmedica’s Gray reamers were introduced about three years ago. They incorporate a unique grommet between the inter- changeable head and shaft to “minimize the possibility of head and shaft separation during ex vivo handling.” In addition, they offer two short (7.5 mm and 8.5 mm diameters) and two standard lengths (240 mm and 420 mm). Howmedica recommends not using shafts in reverse.

FEATURES & BENEFITS TO SELL AGAINST HOWMEDICA • ReversibleSculptO.R. laser cut shaft , while Howmedica’s literature does not recommend.

• Studies show smaller shaft reduces pressure and temperature. The SculptO.R. shaft is 7.5 mm diameter.

• The SculptO.R. system has interchangeable sizes available up to 21.0 mm for IM Nail and Total Hip procedures.

• Howmedica systems do not include fixed reamers, must use grommet to make interchangeable shaft and head act as a fixed reamer extra part and must remember to put it on before surgery.

• Howmedica system does not include sounds.

TM SCULPTO.R. REAMER SYSTEM 22 COMPETITION

ZIMMER ~PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM Zimmer released an improved reamer set at the 1999 AAOS meeting. The original Zimmer’s Pressure Sentinel Reamers were introduced in 1995–1996 and include a smaller shaft design that is intended to reduce hydraulic pressure in the intramedullary canal during reaming.

The new Pressure Sentinel Reamer has a narrow shaft design made of nitinol metal (memory metal) that can be bent but returns to its original shape. The shaft is cannulated to enable reaming over the guide rod; this also makes it very easy to clean.

The cutting head is permanently attached to the shaft, therefore all reamers are considered to be “fixed reamers.” If the cutting head becomes dull the entire part must be replaced rather than only replacing the head. The fixed reamers come in sizes 5.0 mm–22.0 mm in diameter in .5 mm increments. This makes the system more expensive to maintain.

Zimmer offers four convenient sets a Full, Trauma, Basic Hip and Expanded Hip, which allow customization for the customer.

FEATURES & BENEFITS TO SELL AGAINST ZIMMER • Pressure SentinelTM shaft has tendency to not return to original shape, therefore, hard to fit in tray.

• Pressure Sentinel shaft is not as flexible as the SculptO.R. laser cut design.

• If Pressure Sentinel reamer head becomes dull, the entire reamer must be replaced.

• Cost of the system.

• Pressure Sentinel system only includes fixed reamers.

• Pressure Sentinel system does not include sounds.

TM SCULPTO.R. REAMER SYSTEM 23 COMPETITION

BIOMET ~ MODULAR FLEXIBLE REAMER SYSTEM Biomet’s Modular Flexible reamer system has a Kuntscher style reamer head design. The reamer heads are offered with or without a titanium nitride coating, with sizes from 8 mm–20.0 mm in diameter in .5 mm increments.

The reamer shaft has a unique “whip-like” shaft design that makes them reversible during use and easier to clean. This shaft design has been reported to spray blood and debris as the reamer is removed from the canal. Studies have shown that this system performs better, clinically, than the Howmedica and Synthes systems. In comparison to the Biomet system, the new Smith & Nephew reamers have a significantly shorter reaming time and a lower temperature.

The reamer shaft comes in 8 mm diameter in a short 40 cm length and a long 52 cm shaft, which allows for distal reaming when necessary. The reamer shaft uses a 3.2 x 98 cm ball tip guide wire.

FEATURES & BENEFITS TO SELL AGAINST BIOMET • Studies show smaller shaft reduces pressure and temperature. The SculptO.R. shaft is 7.5 mm diameter.

• BIOMET’s Modular Flexible Reamer System only includes fixed reamers, only interchangeable heads.

• BIOMET’s Modular Flexible Reamer System does not include sounds.

TM SCULPTO.R. REAMER SYSTEM 24 CLEANING INSTRUCTIONS

Remove the reamer head from the flexible shaft to clean the reamer assembly. The cannulations of the reamer head and the flexible shaft must be cleaned by running water through the cannulation. The flexible shaft should be flexed during cleaning in order to remove any debris that might have lodged in the coils. The reamer heads and flexible shaft should be sterilized after use.

The following step-by-step Cleaning and Sterilization Methods brochure has been developed for cleaning rooms to follow when cleaning the SculptO.R. Reamer System. Use the following part numbers to order additional copies for your accounts.

Cleaning and Sterilization Methods brochure for Smith & Nephew orthopaedic medical devices:

English Version 7198-0742 French Version 7198-0733 German Version 7198-0734 Spanish Version 7198-0735 Italian Version 7198-0736 Japanese Version 7198-0737

Manual Cleaning Instruction Wallcharts for Smith & Nephew orthopaedic medical devices:

English/Spanish Version 7198-0730 English/French Version 7198-0728 English/Japanese Version 7198-0732 Italian/German Version 7198-0729

Laminated 22x34 Manual Cleaning Instruction Wallchart for Smith & Nephew orthopaedic medical devices:

English/Spanish Version 7198-0743

TM SCULPTO.R. REAMER SYSTEM 25