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Distal Radius Sterile Kit Surgical Technique Table of Contents

Distal Radius Sterile Kit Surgical Technique Table of Contents

For Fragment-Specifi c Fracture Fixation Using the 2.4 mm Variable Angle LCP® Two-Column Volar Distal Radius Plate With Variable Angle Locking Distal Radius Sterile Kit Surgical Technique Table of Contents

Introduction Indications 3

Sterile Kit Variations and Added Instruments 4

Distal Radius Sterile Kit Key Steps 6

Sterile Tube Packaging 7

AO Principles 8

Clinical Cases 9

Surgical Technique Approach 10

Implantation Steps 11

Postoperative Treatment and Implant Removal 21

Product Information 22

MRI Safety Information 28

Bibliography 29

The DePuy Synthes Distal Radius Sterile Kit has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the Distal Radius Sterile Kit in the MR environment is unknown. Scanning a patient who has this device result in patient injury.

Image intensifier control

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 1

Indications

The 2.4 mm Variable Angle LCP® Distal Radius Plates are The DePuy Synthes 2.4/2.7 mm Variable Angle LCP indicated for fi xation of complex intra- and extra-articular Two-Column Volar Distal Radius Plate, Extra-Long is fractures and osteotomies of the distal radius and other intended for intra- and extra-articular fractures, small bones in adults, skeletally mature adolescents, and osteotomies, nonunions, and malunions of the distal the following adolescent distal radius fractures: radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth • Intra-articular fractures exiting the epiphysis plates have fused or will not be crossed, such as: • Intra-articular fractures exiting the metaphysis • Physeal crush injuries • Intra-articular fractures exiting the epiphysis • Any injuries which cause growth arrest to the distal radius • Intra-articular fractures exiting the metaphysis • Physeal crush injuries • Any injuries which cause growth arrest to the distal radius

Precaution: The DePuy Synthes 2.4/2.7 mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long was designed for patients where the growth plates have fused or will not be crossed. The use of the 2.4/2.7 mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long in patients where the growth plates have not fused or will be crossed may result in premature closure of the physis and bone growth inhibition.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 2 Sterile Kit Variations and Added Instruments

Variable Angle LCP Volar and Dorsal Distal Core sterile kits Radius Plates. Core sterile kits contain both the implants and instruments to perform one distal radius surgery with a 3-shaft hole Sterile Instruments and Implants for multi-fragment VA LCP Two-Column Distal Radius Plate. All implants are fracture fixation with variable angle locking technology. available in both Stainless Steel and Titanium.

4 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Sterile Kit Variations and Added Instruments

Sterile instrument kits with individually packed sterile plates and screws Instrument kits are part of a modular system with individually packed sterile plates and screws. They contain only the instruments needed to perform one distal radius surgery with the following DePuy Synthes Variable Angle radius plates:

2.4 mm VA LCP Two-Column Distal Radius Plates 2.4/2.7 mm VA LCP Two-Column Distal Radius Plates, Extra-Long 2.4 mm VA LCP Extra-articular Distal Radius Plate 2.4 mm VA LCP Dorsal Distal Radius Plates

Plates and screws are available single-packed in sterile packaging.

Sizing templates In addition, sterile sizing templates are available separately to determine the correct plate head width of VA LCP Two-Column Distal Radius Plates.

Implant removal screwdriver The single-use T8 screwdriver is designed to facilitate implant removal without the need for a sterile instrument kit. Note that the screwdriver tip is Note: All implants and instruments of the Distal non-retaining to facilitate maximum torque transmission. Radius Sterile Kit are single use. Do not resterilize. Dispose of all unused items after surgery.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 2 Distal Radius Sterile Kit Key Steps

Note: Please refer to the IFU and this surgical technique for full usage information.

1 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Sterile Tube Packaging

The screws contained in the Distal Radius Sterile Kit were Step 3: selected based upon the wide anatomical range they can Circulating Nurse (non-sterile fi eld): cover and historical sale/usage data to maximize the Hold the outer cap and point the inner tube towards the breadth of surgeries in which they can be used. In the sterile fi eld. event the screw length needed for surgery is not contained Scrub Nurse (sterile fi eld): in the kit, additional sterile screws are available. Remove the inner tube by pulling and if necessary slightly twisting the inner tube back and forth to release it from the outer cap. When twisting the tube, hold on to the tube and not the cap.

Leading the Way–Sterile Implants The Sterile Tube concept consists of a solution that uses

2 tubes where one fi ts into the other to allow a streamlined sterile fi eld non-sterile fi eld and secure transfer of sterile implants into the sterile fi eld. Step 4: Open the inner tube by unscrewing the inner cap Follow the following steps to access a sterile screw: from the inner tube and remove the holder with the screw.

Step 1: Tear the pull-strip open to remove the sleeve.

sterile fi eld

Step 5: Engage the screwdriver in the screw recess and if non-sterile fi eld necessary secure with fi nger. Remove the screw from the holder by tilting it out of the holder/tilting the holder Step 2: Open the outer tube by unscrewing the outer cap away at the opening. from the outer tube. Do not touch the inner tube to maintain sterility.

sterile fi eld

non-sterile fi eld For additional usage notes and instructions, see separate Sterile Screw Tube Usage Guide (DSUS/TRM/1216/1243).

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 1 AO Principles AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fxation.1,2 In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.

4_Priciples_03.pdf 1 05.07.12 12:08

AnatomicAnatomic reductionreduction StableStable fixationfixation FractureFracture reductionreduction and fifxation to FractureFracture f fixationxation providing providing absolute abso- restorerestore anatomicalanatomical relationships.relationships. orlute relative or relative stability, stability, as required as by therequired patient, by thethe injury, patient, and the the injury, 1 2 personalityand the personality of the fracture. of the fracture.

Early,Early, activeactive mobilizationmobilization PreservationPreservation of of blood blood supply supply EarlyEarly andand safesafe mobilizationmobilization and 4 3 PreservationPreservation of of the the blood blood supply supply rehabilitationrehabilitation ofof thethe injuredinjured part toto softsoft tissues tissues and and bone bone by by gentle andand thethe patientpatient asas aa whole.whole. reductiongentle reduction techniques techniques and and carefulcareful handling. handling.

1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New : Springer-Verlag; 1991. 2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal 2nd ed. New York: Thieme; 2007. Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991. 2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007. 8 DePuy Synthes Distal Radius Sterile Kit Surgical Technique

4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique Clinical Cases

Case 1 24-year-old male with AO 23C2.1 fracture, fall from scaffold

Preoperative, AP view Preoperative, lateral view Postoperative, AP view Postoperative, lateral view

Case 2 77-year-old female with AO 23C1 fracture, fall

Preoperative, AP view Preoperative, lateral view Postoperative, AP view Postoperative, lateral view

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 9 Approach

Make a longitudinal incision slightly radial to the fl exor carpi radialis tendon (FCR). Dissect between the FCR and the radial artery, exposing the pronator quadratus. Detach the pronator quadratus from the lateral border of the radius and elevate it toward the ulna.

Note: Leave the volar wrist capsule intact to avoid devascularization of the fracture fragments and destabilization of the volar wrist ligaments.

10 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Implantation Steps

1. Select implant

Instrument

03.111.120S 2.4 mm VA LCP 2-Column Volar Distal Radius Plate Templates, sterile

Sizing templates Double-sided sterile sizing templates may be used to identify the desired plate size prior to opening a distal radius sterile kit. Templates are available for 2.4 mm VA LCP Two-Column Volar Distal Radius Plates.

Sizing template choices, for 2.4 mm VA LCP Two-Column Volar Distal Radius Plates (narrow, standard, wide head sizes).

Sizing templates are marked with Left (L) and Right (R) as well as the corresponding plate type (narrow, standard, wide).

Select the correct distal radius sterile kit according to the template matching the bone and fracture pattern with respect to side (left and right, facing up) and size (narrow, standard, wide).

Precaution: Ensure proper plate selection by verifying the L (left) and R (right) etching on the sizing template. The template’s distal lip is slightly lower on the radial side.

Note: Excessive and repetitive bending of the templates should be avoided.

Sizing templates are double-sided (L and R version)

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 11 Implantation Steps

2. Reduce fracture and position plate

Instrument

292.120 1.25 mm Kirschner Wires, with trocar tip

Reduce the fracture The reduction method will be fracture-specific.

Position plate Apply the plate to fit the volar surface.

The order of screw insertion and the use of K-wires may vary depending on the fracture pattern and reduction technique.

If necessary, use 1.25 mm K-wires inserted through the desired Kirschner-wire hole to temporarily fix the plate distally. The distal K-wire holes of the plate are designed to indicate the nominal screw trajectory angle of the screw hole medial to the respective K-wire hole.

Perform several radiographic views of the distal radius to ensure alignment, plate placement, and fracture reduction.

Additional options for preliminary Kirschner wire fi xation

12 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Implantation Steps

3. Insertion of proximal screws

03.111.113 Instruments

03.111.113 1.8 mm Drill Bit, quick coupling 03.111.112 03.111.112 1.8 mm VA/Cortex Drill Guide

03.111.111 1.8 mm Coaxial Drill Guide

03.111.114 2.4/2.7 mm Depth Gauge 03.111.111

03.111.115 0.8 Nm Torque-limiting Screwdriver, T8

Determine where 2.4 mm locking screws and 2.4 mm 03.111.114 cortex screws will be used in the plate. The order of screw insertion in the shaft and metaphysis may vary depending on the fracture pattern and reduction technique.

Verify plate and distal screw location with a drill bit or 03.111.115 K-wires before inserting multiple screws.

Cortex Screws

Drill using VA/Cortex Drill Guide Beginning with the center of the elongated hole in the shaft of the plate, drill with the 1.8 mm drill bit using the 1.8 mm VA/Cortex drill guide.

Note: The 1.8 mm VA/Cortex drill guide should be fully inserted in cortex or VA plate holes. Moderate pressure should be applied to keep guide inserted in plate hole when drilling.

Precaution: Excessive force should be avoided while drilling to avoid bending or damaging the drill.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 12 Implantation Steps

Insertion of proximal screws (continued) Determine screw length of cortex screws Engage the hook of the 2.4/2.7 mm depth gauge at the 2 opposite cortex and shift the sleeve down into the hole (1). 2 Take the reading from the edge of the sleeve (see arrow 2) and select a screw length corresponding to the reading.

1

Insert cortex (non-locking) screw Insert an appropriate length 2.4 mm cortex screw in the elongated hole in the plate shaft. Adjust the plate position if necessary and tighten the screw with the screwdriver.

Depending on fi xation requirements, additional cortex screws may be inserted into remaining unthreaded shaft holes following the steps above.

Note: If dense bone is preventing screw insertion by engaging the torque-limiting function of the screwdriver before the screw head is seated, the torque-limiting stop should be attached to the torque-limiting screwdriver. Then carefully tighten the screw paying attention not to overtighten it. For assembly of the torque-limiting stop refer to chapter “Torque-limiting Stop for Dense Bone.”

14 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Implantation Steps

Insertion of proximal screws (continued) Locking Shaft Screws Drill using the Coaxial Drill Guide For locking screws, carefully insert the 1.8 mm coaxial drill guide into the threaded portion of the shaft hole until it is seated in the desired locking hole. Drill with the 1.8 mm drill bit.

Note: The 1.8 mm coaxial drill guide should be inserted in-axis to the plate hole and tightened until held in plate. Excessive torque should be avoided.

Precaution: Excessive force should be avoided while drilling to avoid bending or damaging the drill.

Determine screw length Use the 2.4/2.7 mm depth gauge to determine the screw length.Take the reading from the edge of the sleeve (see arrow).

Insert a locking screw Using the T8 torque-limiting screwdriver, insert the screw perpendicular to the plate surface until the screw head is seated.

Note: If dense bone is preventing screw insertion by engaging the torque-limiting function of the screwdriver before the screw head is seated, the torque-limiting stop should be attached to the torque-limiting screwdriver. Then carefully tighten the screw paying attention not to overtighten it. For assembly of the torque-limiting stop refer to chapter “Torque-limiting Stop for Dense Bone.”

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 12 Implantation Steps

4. Insertion of distal screws For used instruments, please refer to page 13.

4a. Determine whether screws will be inserted at the pre-defined nominal angle (option 1) or at a variable angle (option 2).

Option 1: Pre-defined angle drilling To follow the nominal trajectory of a locking hole, insert the 1.8 mm coaxial drill guide in-axis to the nominal angle of the plate hole. Drill with the 1.8 mm drill bit.

Precaution: Excessive force should be avoided while drilling to avoid bending or damaging the drill.

Option 2: Variable angle drilling Use the 1.8 mm VA/cortex drill guide. Fully seat it into the VA locking hole. Drill holes at the desired angle with the 1.8 mm drill bit. Moderate pressure should be applied to keep the guide inserted in the plate hole when drilling.

Precaution: To ensure that the screw is locked correctly, do not angle it in excess of +/– 15° from the nominal trajectory of the hole. Excessive force should be avoided while drilling to avoid bending or damaging the drill.

To achieve the desired angle, verify the drill bit angle under image intensifier control. If necessary, drill at a different angle and verify again under image intensifier control.

11 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Implantation Steps

4b. Determine screw length Use the 2.4/2.7 mm depth gauge to determine the screw length.

If the fracture type allows choose a screw length shorter than measured to ensure the screw does not protrude from the dorsal cortex.3,10

4c. Insert VA locking screws Using the T8 torque-limiting screwdriver, insert the screw in the direction of the previously drilled hole until the screw head is seated.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 11 Implantation Steps

5. Ensure proper joint reconstruction Ensure proper joint reconstruction, screw placement and screw length using multiple radiographic views. Verify that the distal screws are not in the joint by using additional views such as a 10° dorsally tilted, 20° inclined lateral, 45° pronated oblique, and the dorsal tangential view.5,6

11 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Implantation Steps

6. Final fi xation of VA locking screws

Instruments

03.111.115 Torque-limiting Screwdriver, T8 03.111.115 03.111.116 Torque-limiting Stop 03.111.116 (optional) Optional: intended to be used only in case of dense bone

Use the T8 torque-limiting screwdriver to perform the final locking step for VA locking screws.

Insert the screw until you hear a click.

The torque-limiting screwdriver prevents over-tightening and ensures that the VA locking screws are securely locked into the plate.

Note: For dense bone, visually inspect if the screw is appropriately threaded and seated after tightening with the torque-limiting screwdriver. If dense bone is preventing screw insertion, the torque-limiting stop should be attached to the torque-limiting screwdriver. Then carefully tighten the screw until the head is fl ush with the plate surface. For a detailed description of screw insertion and assembly of the torque-limiting stop refer to chapter “Torque-limiting Stop for Dense Bone.”

Precaution: Remove the torque-limiting stop from the screwdriver when not necessary to overcome dense bone.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 19 Implantation Steps

Torque-limiting Stop for Dense Bone (optional)

Instruments

03.111.115 Torque-limiting Screwdriver, T8 03.111.115

03.111.116 Torque-limiting Stop 03.111.116 (optional) Optional: intended to be used only in case of dense bone

Visually inspect if the screw is appropriately threaded and seated after tightening with the torque-limiting handle.

If dense bone is preventing screw insertion, the torque-limiting stop should be attached to the torque-limiting handle.

To attach the torque-limiting stop ensure that the triangles on both the torque-limiting stop and the handle are aligned. Rotation may be required for alignment.

Then carefully tighten so that the screw head is fl ush with the plate surface. Confi rm fi nal locking with the torque-limiting stop removed.

Precaution: Remove the torque-limiting stop from the screwdriver when not necessary to overcome dense bone.

20 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Postoperative Treatment and Implant Removal

Postoperative treatment Postoperative treatment with VA locking compression plates does not differ from conventional internal fixation procedures and is at the discretion of the clinician.

Implant removal

Instrument

03.111.117S Screwdriver, T8, non-retaining, sterile For implant removal

The screwdriver for implant removal is not designed for screw retention.

Before attempting screw removal clean all screw head recesses of tissue or ingrown/overgrown bone using a dental pick or other appropriate instrument.

To remove locking screws, first unlock all screws from the plate; then remove the screws completely from the bone.

The last screw removed should be a non-locking screw on the shaft. This prevents the plate from spinning when locking screws are removed.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 22 Product Information

Sterile Implant and Instrument Kits with 2.4 mm VA LCP Two-Column Volar Distal Radius Plates Stainless Steel (316L) Head size Head Shaft Length Left/ Part number (mm) holes holes (mm) Right 02.111.530KS narrow 19.5 6 3 51 R 02.111.531KS narrow 19.5 6 3 51 L 02.111.630KS standard 22 6 3 54 R 02.111.631KS standard 22 6 3 54 L 02.111.730KS wide 25.5 7 3 55 R 02.111.731KS wide 25.5 7 3 55 L Titanium* Head size Head Shaft Length Left/ Part number (mm) holes holes (mm) Right 04.111.530KS narrow 19.5 6 3 51 R 04.111.531KS narrow 19.5 6 3 51 L 04.111.630KS standard 22 6 3 54 R 04.111.631KS standard 22 6 3 54 L 04.111.730KS wide 25.5 7 3 55 R 04.111.731KS wide 25.5 7 3 55 L

Sizing Templates for Two-Column Distal Radius Plates 03.111.120S 2.4 mm VA LCP 2-Column Volar Distal Radius Plate Templates, sterile 03.111.121S Sizing templates for 2.4/2.7 mm VA LCP Two-Column Volar Distal Radius Plates, 03.111.120S 03.111.121S Extra-Long, sterile

Implant Removal Screwdriver 03.111.117S Screwdriver, T8, non-retaining, sterile For implant removal * Plates: commercially pure titanium (CP4); screws: titanium alloy (Ti-6Al-7Nb).

22 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Product Information

Instrument-only Kit 03.111.100S 2.4 mm VA LCP instrument kit, sterile

Individually Packed Sterile Plates Available for use with Instrument-only Kit

2.4 mm VA LCP Two-Column Volar Distal Radius Plates, sterile Narrow, width 19.5 mm Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right 02.111. 04.111.520S 6 2 42 R 02.111.521S 04.111.521S 6 2 42 L 02.111. 04.111.530S 6 3 51 R 02.111.531S 04.111.531S 6 3 51 L 02.111. 04.111.540S 6 4 63 R 02.111.541S 04.111.541S 6 4 63 L 02.111. 04.111.550S 6 5 72 R 02.111.551S 04.111.551S 6 5 72 L Standard, width 22 mm Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right 02.111. 04.111.620S 6 2 45 R 02.111.621S 04.111.621S 6 2 45 L 02.111. 04.111.630S 6 3 54 R 02.111.631S 04.111.631S 6 3 54 L 02.111. 04.111.640S 6 4 66 R 02.111.641S 04.111.641S 6 4 66 L 02.111. 04.111.650S 6 5 75 R 02.111.651S 04.111.651S 6 5 75 L Wide, width 25.5 mm Head Shaft Length Left/ Stainless Steel Titanium holes Holes (mm) Right 02.111. 04.111.720S 7 2 47 R 02.111.721S 04.111.721S 7 2 47 L 02.111. 04.111.730S 7 3 55 R 02.111.731S 04.111.731S 7 3 55 L 02.111. 04.111.740S 7 4 68 R 02.111.741S 04.111.741S 7 4 68 L 02.111. 04.111.750S 7 5 77 R 02.111.751S 04.111.751S 7 5 77 L All plates are sterile packed. Images show selected right plates in both 316L stainless steel and commercially pure titanium (CP4) materials.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 22 Product Information

2.4/2.7 mm VA LCP Two-Column Volar Distal Radius Plates, Extra-Long, sterile

Head size Head Shaft Length Left/ Stainless Steel Titanium (mm) holes holes (mm) Right 02.111. 04.111.570S narrow 19.5 6 7 105 R 02.111.571S 04.111.571S narrow 19.5 6 7 105 L 02.111. 04.111.670S standard 22 6 7 109 R 02.111.671S 04.111.671S standard 22 6 7 109 L 02.111.770S 04.111.770S wide 25.5 7 7 110 R 02.111.771S 04.111.771S wide 25.5 7 7 110 L 02.111. 04.111.680S standard 22 6 10 145 R 02.111.681S 04.111.681S standard 22 6 10 145 L 02.111. 04.111.690S standard 22 6 13 186 R 02.111.691S 04.111.691S standard 22 6 13 186 L

2.4 mm VA LCP Extra-Articular Volar Distal Radius Plates, sterile

Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right 02.110.201S 04.110.201S 5 3 48 R 02.110.203S 04.110.203S 5 3 48 L 02.110.202S 04.110.202S 5 5 66 R 02.110.204S 04.110.204S 5 5 66 L 02.110.205S 04.110.205S 4 3 45 R 02.110.207S 04.110.207S 4 3 45 L 02.110.206S 04.110.206S 4 5 65 R 02.110.208S 04.110.208S 4 5 65 L

All plates are sterile packed. Images show selected right plates in both 316L stainless steel and commercially pure titanium (CP4) materials.

24 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Product Information

2.4 mm VA LCP Dorsal Distal Radius Plates, sterile Radial Column •• Shaft Length Stainless Steel Titanium holes (mm) 02.115.530S 04.115.530S 5 46 02.115.540S 04.115.540S 6 57

Intermediate Column, 2 head holes Note: The plates for the right radius (0x.115.630 and 0x.115.640) are angled left and the plates for the left radius (0x.115.631 and 0x.115.641) are angled right.

•• Shaft Length Stainless Steel Titanium holes (mm) Angle 02.115.630S 04.115.630S 3 41 -90° 02.115.631S 04.115.631S 3 41 +90° 02.115.640S 04.115.640S 4 49 -90° 02.115.641S 04.115.641S 4 49 +90°

L-Plates, 2 head holes •• Shaft Length Stainless Steel Titanium holes (mm) Angle 02.115.130S 04.115.130S 3 37 +90° 02.115.131S 04.115.131S 3 37 -90° 02.115.150S 04.115.150S 5 51 +90° 02.115.151S 04.115.151S 5 51 -90°

L-Plates, 3 head holes •• Shaft Length Stainless Steel Titanium holes (mm) Angle 02.115.230S 04.115.230S 3 37 +90° 02.115.231S 04.115.231S 3 37 -90° 02.115.250S 04.115.250S 5 51 +90° 02.115.251S 04.115.251S 5 51 -90°

All plates are sterile packed. Images show selected right plates in both 316L stainless steel and commercially pure titanium (CP4) materials.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 22 Product Information

L-Plates, oblique, 3 head holes Shaft Length Stainless Steel Titanium holes (mm) Angle 02.115.430S 04.115.430S 3 41 +20° 02.115.431S 04.115.431S 3 41 -20° 02.115.450S 04.115.450S 5 55 +20° 02.115.451S 04.115.451S 5 55 -20°

T-Plates, 3 head holes Shaft Length Stainless Steel Titanium holes (mm) 02.115.330S 04.115.330S 3 37 02.115.350S 04.115.350S 5 51

Note: This Surgical Technique does not include information necessary for selection and use of 2.4/2.7 mm Variable Angle LCP Volar Two-Column Distal Radius Plates Extra-long, 2.4 mm Variable Angle LCP Volar Extra-Articular Distal Radius Plates, and 2.4 mm Variable Angle LCP Dorsal Distal Radius Plates. Please refer to the corresponding Surgical Technique for all necessary implant-specifi c information.

All plates are sterile packed. Images show selected right plates in both 316L stainless steel and commercially pure titanium (CP4) materials.

21 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Product Information

Individually Packed Sterile Screws Ordering Information

2.4 mm Variable Angle Locking Screws, with T8 StarDriveTM Recess, tube sterile Stainless Steel* Titanium* Length (mm) 02.210.108TS 04.210.108TS 8 02.210.110TS 04.210.110TS 10 02.210.112TS 04.210.112TS 12 02.210.114TS 04.210.114TS 14 02.210.116TS 04.210.116TS 16 02.210.118TS 04.210.118TS 18 02.210.120TS 04.210.120TS 20 02.210.122TS 04.210.122TS 22 02.210.124TS 04.210.124TS 24 02.210.126TS 04.210.126TS 26 02.210.128TS 04.210.128TS 28 02.210.130TS 04.210.130TS 30

2.4 mm Cortex Screws, with T8 StarDrive Recess, tube sterile Stainless Steel* Titanium* Length (mm) 201.758TS 401.758TS 8 201.760TS 401.760TS 10 201.762TS 401.762TS 12 201.764TS 401.764TS 14 201.766TS 401.766TS 16 201.768TS 401.768TS 18 201.770TS 401.770TS 20 201.772TS 401.772TS 22 201.774TS 401.774TS 24 201.776TS 401.776TS 26 201.778TS 401.778TS 28 201.780TS 401.780TS 30

* 316L Stainless Steel Titanium Alloy (Ti-6AI-7Nb)

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 21 MRI Safety Information

These devices have not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of these devices in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

22 DePuy Synthes Distal Radius Sterile Kit Surgical Technique Bibliography

1. Brink PR, Rikli DA. Four-corner concept: CT-based assessment of fracture patterns in distal radius. J Wrist Surg. 2016;5:147-51. 2. Hart A, Collins M, Chhatwal D, Steffen T, Harvey EJ, Martineau PA. Can the use of variable-angle volar locking plates compensate for suboptimal plate positioning in unstable distal radius fractures? A biomechanical study. J Orthop Trauma. 2015;29:1-6. 3. Löw S, Herold D, Eingartner C. Standardized palmar plating of dorsally displaced distal radius fractures. Tech Hand Up Extrem Surg. 2013;17:106-11. 4. Oppermann J, Wacker M, Stein G, Springorum HP, Neiss WF, Burkhart KJ, Eysel P, Dargel J. Anatomical ft of seven different palmar distal radius plates. Arch Orthop Trauma Surg. 2014;134:1483-9. 5. Ozer K, Wolf JM, Watkins B, Hak DJ. Comparison of 4 fluoroscopic views for dorsal cortex screw penetration after volar plating of the distal radius. J Hand Surg Am. 2012;37:963-7. 6. Pace A, Cresswell T. Use of articular wrist views to assess intra-articular screw penetration in surgical fxation of distal radius fractures. J Hand Surg Am. 2010;35:1015-8. 7. Rausch S, Klos K, Stephan H, Hoffmeier K, Gras F, Windolf M, Gueorguiev B, Hofmann GO, Mückley T. Evaluation of a polyaxial angle-stable volar plate in a distal radius C-fracture model—a biomechanical study. Injury. 2011;42:1248-52. 8. Rausch S, Schlonski O, Klos K, Gras F, Gueorguiev B, Hofmann GO, Mückley T. Volar versus dorsal latest-generation variable-angle locking plates for the fxation of AO type 23C 2.1 distal radius fractures: a biomechanical study in cadavers. Injury. 2013;44:523-6. 9. Stanbury SJ, Salo A, Elfar JC. Biomechanical analysis of a volar variable-angle locking plate: the effect of capturing a distal radial styloid fragment. J Hand Surg Am. 2012;37:2488-94. 10. Tarallo L, Mugnai R, Zambianchi F, Adani R, Catani F. Volar plate fxation for the treatment of distal radius fractures: analysis of adverse events. J Orthop Trauma. 2013;27:740-5.

Distal Radius Sterile Kit Surgical Technique DePuy Synthes 22 Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or ftness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identifed in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets.

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