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Distal Radius Sterile Kit Surgical Technique Table of Contents

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For Fragment-Specifi c Fracture Fixation Using the 2.4 mm Variable Angle LCP® Two-Column Volar Distal Radius Plate With Variable Angle Locking Technology 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 may 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 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 reductionreduction StableStable fixationfixation FractureFracture reductionreduction and fixation to FractureFracture fi 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 York: 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. Stuttgart 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.
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