INBONE™ Total Ankle System

IMPLANT REMOVAL SURGICAL TECHNIQUE SURGEON DESIGN TEAM

The INBONE™ Total Ankle System Removal Surgical Technique was developed in conjuction with:

Steven L. Haddad, MD Illinois Bone and Joint Institute Chicago, IL ™ INBONE Robert B. Anderson, MD Total Ankle System Titletown Sports Medicine and Orthopedics Green Bay, WI

REMOVAL SURGICAL TECHNIQUE Gregory C. Berlet, MD Orthopedic Foot and Ankle Center Columbus, OH

W. Hodges Davis, MD OrthoCarolina Charlotte, NC

William C. McGarvey, MD Memorial Hermann Katy Hospital Katy, TX

Murray J. Penner, MD FRCSC Providence Health Care Vancouver, BC Contents

Chapter 1 4 Removal Surgical Technique 4 Poly Insert Removal 5 Talar Component Removal 5 Tibia Component Removal 5 Morse Taper Release 6 Assemble C-Bracket Adapter 8 Build the C-Bracket Assembly 10 Drill Primary Hole 14 Ream the Tibia 17 Extraction Wrench Approach 18 Retrieving a Mid or Top Stem Piece from the Tibia 19 Offset Wrenches

Appendix A 20 INBONE™ Removal Instrumentation

Appendix B 21 Ordering Information

Appendix C 22 Hole Saw Specifications

Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package inserts (151678) for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the package insert is available on the website listed: wright.com, under the link for Prescribing Information. Please contact your local Wright representative for product availability.

3 Removal Surgical Technique chapter 1

Poly Insert Removal Option 1 To remove the Poly Insert, first install two large diameter threaded Steinmann Pins into the anterior face of the implant. With a pair of pliers (RR3034) pull distally on the Steinmann Pins in attempt to unlock the Insert from the Tibial Tray.

If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation. Wire Pliers RR3034

Option 2 An alternative way to remove the Poly Insert is to predrill the anterior face of the implant with a drill no larger than 2.8mm. Using a pin driver, insert the Bone Removal Screw (IB200051) into the predrilled hole. Attach the Ratcheting Handle (44180025) to the Bone Removal Screw and pull distally on the Handle in an attempt to unlock the Insert from the Tibial Tray. Bone Removal Screw For both options a narrow osteotome may be inserted into the anterior region IB200051 of the insert to facilitate removal. A hemostat may be used to remove the insert once it is no longer locked to the tibial base.

Ratcheting Handle 44180025

4 Chapter 1 INBONE™ Removal Surgical Technique Tibia and Talar Components To remove the components, small osteotomes, power saws, or other surgical instruments may be used to disrupt the bone-cement interface. Care must be exhibited to save remaining bone stock as well as to prevent fracture. Once the components have been removed, rongeurs or small osteotomes as well as other surgical instruments may be used to remove the remaining cement.

Morse Taper Release Thread Morse Taper Release Pin (200356003) into Morse Taper Release Handle (200355). FIGURE 1 Insert tip of the Morse Taper Release Pin into the Morse Taper Release Hole of the Implant. Angled surface of the Release Pin should face distally. Strike the end of the Morse Taper Release Handle with a mallet until the Morse Taper becomes unseated. FIGURE 2

Morse Taper Release Handle Morse Taper Release Pin, 3mm (200355) (200356003)

(Assembled Tool) FIGURE 1

Talar Dome Tibial Tray

Base Stem Morse Taper Talar Dome Release Hole

Threaded hole for holding tool

Morse Taper Release Pin Tibial Tray Morse Taper Release hole Morse Taper Release Pin

Talar Dome

Morse Taper Release hole

Talar Stem FIGURE 2 Note pin orientation

CAUTION: Release pin must be inserted into the Talar Dome from anterior to posterior to disengage taper. Failure to do so could result in pin becoming permanently jammed.

Chapter 1 INBONE™ Removal Surgical Technique 5 Assemble C-Bracket Adapter Identify the size of the implanted tibial base stem. Select the Base Stem Insert (66502016 or 66502018) that matches the size of the base stem. Thread the Base Stem Insert into C-Bracket Adapter (66502000) and Adapter Screw Adjust (66502001) into C-Bracket Adapter so that the round face of the Adapter Screw Adjust is facing the assembled Base Stem Insert. FIGURE 3

16mm 18mm Base Stem Insert 66502016 — 66502018

FIGURE 3

Fit the Base Stem Insert inside of the morse taper of the implanted base stem. Make sure that the adapter is firmly in place. If necessary, place a laminar spreader against the talus and the distal side of the adapter. FIGURE 4

C-Brackett Adapter 66502000

Adapter Screw Adjust 66502001

FIGURE 4 FIGURE 5 Adjust the adapter adjustment screw to fit securely on the leg so that the adapter is parallel to the base stem face. FIGURE 5

6 Chapter 1 INBONE™ Removal Surgical Technique Place the metal Anterior Mounting Plate (PTA00040) onto the anterior surface of C-Bracket Adapter The two metal dowel pins protruding from the back side of the Anterior Mounting Plate are designed to fit into round holes of the C-Bracket Adapter. The two flat mating surfaces must be fully seated. Insert three 2.4mm Steinmann Pins through the Anterior Mounting Plate (one proximal, one medial and one lateral) and into the tibia. Cut the proximal tibial pin flush to surface of the guide. Using the Wire Pliers (RR3034), bend the medial and lateral pins in order to secure the Anterior Mounting Plate to the C-Bracket Adapter. FIGURE 6

Anterior Mounting Plate PTA00040

FIGURE 6

Chapter 1 INBONE™ Removal Surgical Technique 7 Build the C-Bracket Assembly Connect the Toe Plate (PTA00050) and the Bushing Attachment (PTA00020) to the C-Bracket (PTA00010). FIGURE 7 The C-Bracket is symmetrically designed to be used on either the medial or lateral side of the foot based on surgeon preference.

Toe Plate PTA00050

C-Bracket PTA00010

Bushing Attachment PTA00020

FIGURE 7

Assembled C-Bracket

8 Chapter 1 INBONE™ Removal Surgical Technique It is recommended to place a surgical bump under the Achilles prior to drilling through the C-Bracket. FIGURE 8 By placing a bump proximal to the talus, it will prevent the back of the heel from resting on the surgical table and potentially translating anterior in relation to the tibia. When properly aligned, the C-Bracket will place the 6mm drill inline with the tibial base stem. Verify proper alignment with a lateral fluoroscopic image. FIGURE 9

FIGURE 8 Bump

Surgical Table

Parallel to the Tibial Base Stem

FIGURE 9 Chapter 1 INBONE™ Removal Surgical Technique 9 Drill Primary Hole Lower the C-Bracket assembly down over the Anterior Mounting Plate and attach through the two protruding dowel pins. FIGURE 10 The surface of the C-Bracket arm must sit flat against the Anterior Mounting Plate.

FIGURE 10

Secure the C-Bracket to the Anterior Mounting Plate by rotating the swivel rod up and over the C-Bracket arm and tightening the screw on the end of the swivel rod. FIGURES 11, 12, and 13

C-Bracket Arm

FIGURE 11 FIGURE 12 FIGURE 13 Swivel Rod & Screw

10 Chapter 1 INBONE™ Removal Surgical Technique Place the foot in slight dorsiflexion. Press and hold in the slide lock button on the outside arm of the C-Bracket and slide the distal end of the C-Bracket assembly close to the bottom of the foot. Leave a slight gap between the heel and the Bushing Attachment to facilitate it’s removal. FIGURE 14 To prevent the C-Bracket assembly from binding while adjusting the length, push the bottom of the assembly in-line with the side rods. Also, sterile mineral oil can be used to lubricate the side rods. Release the slide lock button and tighten the slide lock knob to lock the position of the C-Bracket. With a skin marker, put ink on the tip of the Trocar (200099) and insert into the Cannula (200166). Insert the Trocar and Cannula through the Bushing Attachment and push the tip against the skin to mark the incision point. FIGURE 15

FIGURE 14

Trocar FIGURE 15 Cannula Slide Lock Button

Remove the Trocar and Cannula and push the Bushing Release Button on the C-Bracket to remove the Bushing Attachment. Centering on the previously marked spot, insert a #15 Scalpel and make a 1cm vertical incision in the bottom of the heel. FIGURE 16

Trocar 200099

Scalpel FIGURE 16

Cannula 200166

Chapter 1 INBONE™ Removal Surgical Technique 11 Reattach the Bushing Attachment to the C-Bracket, and re-insert the Trocar and Cannula, pushing through soft tissue in the bottom of the foot, rotating the Cannula until it lightly contacts the calcaneus.

CAUTION: Pushing too hard on the calcaneus will disturb alignment.

Lock the Cannula in place by tightening the outer knob of the Drill Bushing. Remove the Trocar and place the 6mm Drill (200134) through the Cannula and slowly peck-drill through the calcaneus and talus. FIGURE 17 The tip of the 6mm Drill will stop when it impacts the C-bracket Adapter.

FIGURE 17

6mm Drill

A lateral fluoro image will show the 6mm Drill aligned with the tibial base stem. FIGURE 18

6mm Drill 200134

FIGURE 18

12 Chapter 1 INBONE™ Removal Surgical Technique Release the screw and swivel rod attachment from the Anterior Mounting Plate. Release the slide lock on the side arm of the C-Bracket Assembly and, with the Reamer Drive Rod still in the foot, slide the distal portion of the C-Bracket Assembly away from the bottom of the foot. Release the Toe Plate Attachment from the C-Bracket Assembly by pressing the button on the side of the foot plate. FIGURE 19

Toe Plate Attachment

FIGURE 19

Release the Bushing Attachment from the C-Bracket Assembly by pressing the button on the side of the Foot Plate. Lift the C-Bracket off the foot anteriorly leaving the Bushing Attachment on the 6mm Drill. FIGURE 20

FIGURE 20

Chapter 1 INBONE™ Removal Surgical Technique 13 Remove the Anterior Mounting Plate and C-bracket Adapter from the joint space and slide the Bushing Attachment along the 6mm Drill until it contacts the bottom of the foot and secure to the calcaneus with three 2.4mm Steinmann Pins. Two pins can be inserted through the bottom holes of the bushing attachment (one medial and one lateral) with the 3rd pin in one of the top hole locations (preferably on the lateral side). FIGURE 21

FIGURE 21

Ream the Tibia Withdraw the 6mm Drill and immediately replace with the Left Handed Reamer Drive Rod (66500016) with a Jacobs chuck attached. Select the Hole Saw (66503014 — 66503218) based on the size of the Tibial Stem being removed. There are hole saws that are designed to cut around 14mm, 16mm, and 18mm tibial stems. Each size has a hole saw designed to cut around Left Handed Reamer Drive Rod a single stem FIGURE 22 and a hole saw designed to cut around two connected 66500016 stems. FIGURE 23 The taller two stem hole saws may be difficult to fit into the joint space unless the base stem is removed first.

Hole Saw 66503014 — 66503218

FIGURE 22 FIGURE 23

14 Chapter 1 INBONE™ Removal Surgical Technique Using the Holding Clip (200381001 — 200381003), insert the Hole Saw. Using a counterclockwise rotation, manually thread the LH Reamer Driver to avoid cross threading. FIGURE 24

CAUTION: Do not use a Powered Drill to attach the Hole Saw. There is a high risk of cross-threading the Hole Saw using a Power Driver.

Tibial Stem Clip 200381001 — 200381003

FIGURE 24

With the driver in reverse, ream around the tibial stem in the tibial IM canal until the hole saw teeth reach the top of the stem. The four ¼” holes on the hole saw can be used as a fluoroscopic indication of cutting depth. When the hole saw has cut to the desired depth, there should be no daylight visible through the holes. FIGURE 25

FIGURE 25

Chapter 1 INBONE™ Removal Surgical Technique 15 With the driver in reverse, pull the reamer back into the joint space. The tibial stem that was cut around may have unthreaded from the other stems during reaming or retrieval.

CAUTION: Do not put the drill into forward rotation while the Hole Saw is still in the tibia, as it will become unthreaded and remain in the tibia.

The appropriately sized Tibial Stem Wrench (200380001 — 200380003) can be used to disassemble the Hole Saw from the LH Drive Rod. The Wrench must be oriented so that the distal label is facing the proximal end of the tibia to slide on to the wrench flats of the Hole Saw. FIGURE 26 With the Tibial Stem Wrench held in place, rotate the LH Drive Rod clockwise to unthread from the Hole saw.

Tibial Stem Wrench 200380001 — 200380003

FIGURE 26

Alternatively, an instrument may be placed in one of the hole saw’s ¼” holes to provide the rotational resistance needed to break the threaded connection between the hole saw and the drive rod. FIGURE 27 Remove the hole saw from the joint space.

FIGURE 27

16 Chapter 1 INBONE™ Removal Surgical Technique Extraction Wrench Approach The Extraction Wrench (66500022) may be used to break fixation of the entire tibial stem construct by jarring the construct distally into the joint space carefully. Resect the bone covering the wrench flats of the tibial base stem. The appropriately sized end of the wrench will engage the wrench flats. The system works best when the extraction wrench tip is positioned as posterior as possible. FIGURE 28

Impact with Mallet

Extraction Wrench 66500022

FIGURE 28

Provide Counter Pressure with hand

Position a hand on the extraction wrench as far from the patient as possible. Holding tightly to the wrench, impact the wrench proximally to distally with a mallet. Take care to not impact near the hand. FIGURE 28

An alternative method for jarring the construct requires the reamer T-handle passing through a 6mm hole through the bottom of the foot. Thread the T-handle to the distal part of the wrench. Pull distally on the T-handle to jar the stem construct free. FIGURE 29

FIGURE 29

If the Tibial Stems are successfully jarred free, please proceed to the stem disassembly procedure. If the stems remain well-fixed, remove the Tibial Base Stem.

Insert the X-Drive (200071) through the Bushing Attachment and up through the talus. Engage the X-Drive and unthread the stems from one another. Retrieve the released stem from the joint space. X-Drive Repeat the method of reaming the tibia with the Hole Saws over the remaining Tibial 200071 Stems. Where necessary, remove individual stems by disconnecting them from the remaining construct. Retrieve the disassembled stems.

Chapter 1 INBONE™ Removal Surgical Technique 17 Retrieving a Mid or Top Stem Piece from the Tibia Insert the T-Handle Reamer (200395) through the bottom of the foot and thread the Mid/Top Stem Extraction Tool (200102) in the open joint space. FIGURE 30 A size 14 Clip (200381001) is used to introduce the Mid/Top Stem Extraction Tool. Once it is threaded onto the Reamer Drive Rod, replace the Clip with a size 14 Wrench (020038001) to tighten. FIGURE 31

Mid/Top Stem Extraction Tool 200102

Tibial T-Handle Reamer FIGURE 30 FIGURE 31 Drive Rod 200395 Remove the Wrench and push the Extraction Tool up in the tibia until contact is made with the Stem Piece. Continue to turn the T-handle clockwise to engage the threads of the Stem Piece. A 2.4mm Steinmann Pins may be inserted bi-cortically proximal of the top stem so that the construct isn’t forced further proximal in the IM canal. FIGURE 32 Once threads are engaged, pull out the stem construct until the base stem is visible in the joint space. FIGURE 33

FIGURE 32 FIGURE 33

Place the appropriate size Wrench on the stem and turn the T-handle counter- clockwise to disengage the Extraction Tool from the Stem. FIGURE 34 Use the size 14 Wrench to remove the Extraction Tool from the T-Handle Reamer. FIGURE 35

FIGURE 34 FIGURE 35 If difficulty arises during retrieval, clockwise rotation of the T-handle may be used to further break fixation of the stems from the IM canal.

18 Chapter 1 INBONE™ Removal Surgical Technique Offset Wrenches The Offset Wrenches (66501216 - 66501418) may be used to disassemble the tibial stems in the joint space. Unlike other tibial wrenches, they may be rotated in a proximal or distal facing orientation while still being able to engage the stem wrench flats. FIGURE 36

Extraction Wrench 66501216 - 66501418

FIGURE 36

Chapter 1 INBONE™ Removal Surgical Technique 19 INBONE™ Removal

Instrumentation Appendix A

6650KIT1 INBONE™ Implant Removal Set

1 2

3 6 4 5

14 9 10 11

7 8 12 13

1. INBONE™ DRIVE LEFT-HANDED REAMER (66500016) 2. INBONE™ EXTRACTION WRENCH (66500022) 3. INBONE™ COMBO WRENCH 12MM/16MM (66501216) 4. INBONE™ COMBO WRENCH 14MM/18MM (66501418) 5. PROPHECY™ C-BRACKET ADAPTER (66502000) 6. PROPHECY™ ADAPTER SCREW ADJUST (66502001) 7. PROPHECY™ ADAPTER 16MM INSERT (66502016) 8. PROPHECY™ ADAPTER 18MM INSERT (66502018) 9. INBONE™ HOLE SAW 14MM (66503014) 10. INBONE™ HOLE SAW 16MM (66503016) 11. INBONE™ HOLE SAW 18MM (66503018) 12. INBONE™ HOLE SAW 14MM TALL (66503214) 13. INBONE™ HOLE SAW 16MM TALL (66503216) 14. CASE TAR IMPLANT REMOVAL KIT (66504000)

Not included in MAP Kits

20 Appendix A INBONE™ Removal Instrumentation Ordering Information Appendix B

Part# Description 66500016 INBONE™ DRIVE, LH REAMER 66500022 INBONE™ EXTRACTION WRENCH 66501216 INBONE™ COMBO WRENCH 12MM/16MM 66501418 INBONE™ COMBO WRENCH 14MM/18MM 66502000 PROPHECY™ C-BRACKET ADAPTER 66502001 PROPHECY™ ADAPTER SCREW ADJUST 66502016 PROPHECY™ ADAPTER 16MM INSERT 66502018 PROPHECY™ ADAPTER 18MM INSERT 66503014 INBONE™ HOLE SAW, 14MM 66503016 INBONE™ HOLE SAW, 16MM 66503018 INBONE™ HOLE SAW, 18MM 66503214 INBONE™ HOLE SAW, 14MM TALL 66503216 INBONE™ HOLE SAW, 16MM TALL 66503218 INBONE™ HOLE SAW, 18MM TALL

Appendix B Ordering Information 21 Hole Saw

Specifications Appendix C

Cutting Diameter

Cutting Depth Hole Saw Height

Hole Saw Specifications Part# Tibial Stem Size Cutting Diameter Cutting Depth Hole saw Height 66503014 14 17 10 17 66503016 16 19 10 17 66503018 18 21 14 21 66503214 14 17 19 27 66503216 16 19 19 27 66503218 18 21 27 35

Appendix C Hole Saw Specifications 22

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AP-011430B 10-May-2019