Sterile Distal Radius Kit Surgical Technique Image Intensiﬁer Control

Home , 530s, 630s, 640s, 650s, 670s, 730s

For Fragment-Specifi c Fracture Fixation Using the Variable Angle LCP® Two-Column Volar Distal Radius Plate 2.4 With Variable Angle Locking Technology Sterile Distal Radius Kit Surgical Technique Image intensiﬁer control

Warning This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance 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 Information 28

Bibliography 29

Sterile Distal Radius Kit Surgical Technique DePuy Synthes 1 2 DePuy Synthes Sterile Distal Radius Kit Surgical Technique Indications

Variable Angle LCP® Two-Column Volar Distal Radius Plates 2.4 are indicated for the ﬁxation of intra- and extra-articular fractures and osteotomies of the distal radius.

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

Variable Angle LCP® Volar and Dorsal Distal Core sterile kits Radius Plates 2.4. 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 2.4. All implants fracture fixation with variable angle locking technology. are available in both Stainless Steel and Titanium.

Extra screws are provided single-packed in sterile packaging.

4 DePuy Synthes Sterile Distal Radius 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:

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

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

Trial implants In addition, sterile trial implants are available separately to determine the correct plate length and 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 Sterile non-retaining to facilitate maximum torque transmission. Distal Radius Kit are single use. Do not resterilize. Dispose of all unused items after surgery.

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

Note: Please refer to the corresponding IFU (www.depuysynthes.com/ifu) and this surgical technique for full usage information.

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

The amount and lengths of screws contained in the Step 3: Distal Radius Single Use Kit has been identifi ed both Circulating Nurse (non-sterile fi eld): scientifi cally to fi t various anatomies and through historical Hold the outer cap and point the inner tube towards sales data. For most cases, the kit will contain screws of the sterile fi eld. suffi cient length. It is recommended to measure each Scrub Nurse (sterile fi eld): hole’s depth to determine the correct screw length based Remove the inner tube by pulling and if necessary slightly on the current recommendation of the literature.3,10 twisting the inner tube back and forth to release it from the outer cap. When twisting the tube, hold on to the Extra screws that are not contained in the kit are tube and not the cap. available individually packed in sterile tubes.

sterile fi eld non-sterile fi eld Leading the Way to Sterile Implants Step 4: Open the inner tube by unscrewing the inner cap The Sterile Tube concept consists of a solution that from the inner tube and remove the holder with the screw. uses 2 tubes where one fi ts into the other to allow a streamlined and secure transfer of sterile implants into the sterile fi eld.

Follow the following steps to access a sterile 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 necessary secure with fi nger. Remove the screw from the holder by tilting it out of the holder/tilting the holder away at the opening.

non-sterile fi eld

Step 2: Open the outer tube by unscrewing the outer cap from the outer tube. Do not touch the inner tube to maintain sterility.

sterile fi eld

non-sterile fi eld

Sterile Distal Radius 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 fixation.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 reduction reduction StableStable fixation fixation FractureFracture reduction reduction and and ﬁxation fixation to to FractureFracture fixation ﬁxation providingproviding absolute abso- restorerestore anatomical anatomical relationships. relationships. orlute relative or relative stability, stability, as required as by therequired patient, by the the injury, patient, and the the injury, 1 2 personalityand the personality of the fracture. of the fracture.

Early,Early, active active mobilization mobilization PreservationPreservation of of blood blood supply supply EarlyEarly and and safe safe mobilization mobilization and and 4 3 PreservationPreservation of of the the blood blood supply supply rehabilitationrehabilitation of ofthe the injured injured part part toto soft soft tissues tissues and and bone bone by by gentle andand the the patient patient as asa whole.a whole. reductiongentle reduction techniques techniques and and carefulcareful handling. handling.

1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991. 2 Rüedi1. Müller TP, RE ME, Buckley, Allgöwer CG M,Moran. Schneider AO PrinciplesR, Willenegger of Fracture H. Manual Management. of Internal Fixation . 2nd ed.3rd Stuttgart,ed. Berlin, NewHeidelberg, York: Thieme. New York: 2007. Springer-Verlag; 1991. 2. Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart New York: Thieme; 2007.

8 DePuy Synthes Sterile Distal Radius 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

Sterile Distal Radius 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 Sterile Distal Radius Kit Surgical Technique Implantation Steps

1. Select implant

Instrument

03.111.120S Trial Implants for VA-LCP Two-Column Distal Radius Plate 2.4, sterile

Trial implants Double-sided sterile trial implants may be used to identify the desired plate size prior to opening a distal radius sterile kit. Trial implants with 3 shaft holes are available for VA-LCP Two-Column Volar Distal Radius Plates 2.4. Trial implant choices, for VA-LCP Two-Column Volar Distal Radius Plates 2.4 (narrow, standard, wide head sizes).

Trial implants 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 trial implant 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 trial implant. The trial implant’s distal lip is slightly lower on the radial side.

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

Trial implants are double-sided (L and R version).

Sterile Distal Radius Kit Surgical Technique DePuy Synthes 11 Implantation Steps

2. Reduce fracture and position plate

Instrument

292.120 Kirschner Wires Ø 1.25 mm, 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 Additional options for preliminary Kirschner wire fi xation fracture reduction.

12 DePuy Synthes Sterile Distal Radius 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.

Sterile Distal Radius 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 (2) and select a screw length corresponding to the reading.

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 Sterile Distal Radius 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.

Sterile Distal Radius 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 Sterile Distal Radius 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.

Sterile Distal Radius 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 Sterile Distal Radius 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.

Sterile Distal Radius 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 Sterile Distal Radius 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.

Sterile Distal Radius Kit Surgical Technique DePuy Synthes 22 Product Information

Sterile Implant and Instrument Kits with VA-LCP Two-Column Volar Distal Radius Plates Stainless Steel* 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

Trial Implants for Two-Column Distal Radius Plates 03.111.120S Trial Implants for VA-LCP Two-Column Distal Radius Plates 2.4, sterile 03.111.121S Trial Implants for VA-LCP Two-Column Distal Radius Plates 2.4/2.7, Extra-Long, sterile 03.111.120S 03.111.121S

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

* Plates and screws are made from stainless steel (316L). ** Plates are made from commercially pure titanium (TiCP), and screws are made from titanium alloy (Ti-6Al-7Nb).

22 DePuy Synthes Sterile Distal Radius Kit Surgical Technique Product Information

Instrument-only Kit 03.111.100S VA-LCP Instrument Kit 2.4, sterile

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

VA-LCP Two-Column Volar Distal Radius Plates 2.4, sterile Narrow, width 19.5 mm Head Shaft Length Left/ Stainless Steel Titanium holes holes (mm) Right 02.111.520S 04.111.520S 6 2 42 R 02.111.521S 04.111.521S 6 2 42 L 02.111.530S 04.111.530S 6 3 51 R 02.111.531S 04.111.531S 6 3 51 L 02.111.540S 04.111.540S 6 4 63 R 02.111.541S 04.111.541S 6 4 63 L 02.111.550S 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 02.111.620S 04.111.620S 6 2 45 R 02.111.621S 04.111.621S 6 2 45 L 02.111.630S 04.111.630S 6 3 54 R 02.111.631S 04.111.631S 6 3 54 L 02.111.640S 04.111.640S 6 4 66 R 02.111.641S 04.111.641S 6 4 66 L 02.111.650S 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 02.111.720S 04.111.720S 7 2 47 R 02.111.721S 04.111.721S 7 2 47 L 02.111.730S 04.111.730S 7 3 55 R 02.111.731S 04.111.731S 7 3 55 L 02.111.740S 04.111.740S 7 4 68 R 02.111.741S 04.111.741S 7 4 68 L 02.111.750S 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 stainless steel (316L) and commercially pure titanium (TiCP) materials.

Sterile Distal Radius Kit Surgical Technique DePuy Synthes 22 Product Information

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

Head size Head Shaft Length Left/ Stainless Steel Titanium (mm) holes holes (mm) Right 02.111.570S 04.111.570S narrow 19.5 6 7 105 R 02.111.571S 04.111.571S narrow 19.5 6 7 105 L 02.111.670S 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 02.111.680S 04.111.680S standard 22 6 10 145 R 02.111.681S 04.111.681S standard 22 6 10 145 L 02.111.690S 04.111.690S standard 22 6 13 186 R 02.111.691S 04.111.691S standard 22 6 13 186 L

VA-LCP Extra-Articular Volar Distal Radius Plates 2.4, 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 66 L 02.110.202S 04.110.202S 5 5 48 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 65 L 02.110.206S 04.110.206S 4 5 45 R 02.110.208S 04.110.208S 4 5 65 L

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

24 DePuy Synthes Sterile Distal Radius Kit Surgical Technique Product Information

VA-LCP Dorsal Distal Radius Plates 2.4, 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 04.115.650S 4 49 +90° 02.115.641S 04.115.651S 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 stainless steel (316L) and commercially pure titanium (TiCP) materials.

Sterile Distal Radius 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 04.115.330 3 37 02.115.350S 04.115.350 5 51

Note: This Surgical Technique does not include information necessary for selection and use of Variable Angle LCP Extra-Articular Volar Distal Radius Plates 2.4 and Variable Angle LCP Dorsal Distal Radius Plates 2.4. 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 stainless steel (316L) and commercially pure titanium (TiCP) materials.

21 DePuy Synthes Sterile Distal Radius Kit Surgical Technique Product Information

Individually Packed Sterile Screws Ordering Information

Variable Angle Locking Screws Ø 2.4 mm, with T8 StarDrive 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

Cortex Screws Ø 2.4 mm, 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

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

Sterile Distal Radius Kit Surgical Technique DePuy Synthes 22 MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07 Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic ﬁeld of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11a Non-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5°C with an average temperature rise of 6.6°C (1.5 T) and a peak temperature rise of 5.9°C (3 T) under MRI Conditions using RF Coils [whole body averaged speciﬁc absorption rate (SAR) of 2 W/kg for 6 minutes (1.5 T) and for 15 minutes (3 T)].

Precautions: The above mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the speciﬁc absorption rate (SAR) and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients undergoing MR scanning for perceived temperature and/or pain sensations. – Patients with impaired thermo regulation or temperature sensation should be excluded from MR scanning procedures. – Generally it is recommended to use a MR system with low ﬁeld strength in the presence of conductive implants. The employed SAR should be reduced as far as possible. – Using the ventilation system may further contribute to reduce temperature increase in the body.

22 DePuy Synthes Sterile Distal Radius 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 fit 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 fixation 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 fixation 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 fixation for the treatment of distal radius fractures: analysis of adverse events. J Orthop Trauma. 2013;27:740-5.

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