7.0 mm Cannulated Screws

Transcription

1 Part of the DePuy Synthes Cannulated Screw System 7.0 mm Cannulated Screws Surgical Technique

2 Table of Contents Introduction 7.0 mm Cannulated Screws 2 AO Principles 3 Indications 4 Surgical Technique Surgical Technique Information 5 Percutaneous Technique 6 Open Technique 11 Implant Removal 13 Product Information Implants 14 Instruments 15 Set List 18 MR Information The 7.0 mm Cannulated Screw System 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 7.0 mm Cannulated Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Image intensifier control 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 1

3 7.0 mm Cannulated Screws Features Cannulated shaft accepts 2.0 mm diameter guide wires (threaded and nonthreaded wires available). Hemispherical head ensures optimal annular contact with washers and DePuy Synthes plates when screws are angled. Standard 3.5 mm hexagonal drive is compatible with screwdrivers in other commonly used DePuy Synthes sets. Reverse-cutting flutes assist in screw removal. Choice of thread lengths offers best fit of threads into far bone fragment, for greater interfragmentary compression. Cancellous thread profile uses deep cutting threads with a large pitch to increase resistance to pullout. The large pitch also accelerates screw insertion and removal. 2.0 mm guide wire 8.0 mm diameter head with 3.5 mm hex drive Spherical underside 4.5 mm diameter shaft Reverse-cutting flutes Cancellous thread design Thread lengths 16 mm thread 32 mm thread Fully threaded Materials Implant quality 316L stainless steel 2 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

4 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 fixation 1, 2. 4_Priciples_03.pdf :08 Anatomic Anatomic reduction reduction Fracture Fracture reduction reduction and and fixation fixation to to restore restore anatomical anatomical relationships. relationships. 1 2 Stable Stable fixation fixation Fracture Fracture fixation fixation providing providing absolute absolute or relative or relative stability, stability, as required as by the required patient, by the the injury, patient, and the the injury, personality and the personality of the fracture. of the fracture. Early, active mobilization Early Early and and safe safe mobilization and rehabilitation of of the injured part and and the the patient as as a whole. 4 3 Preservation Preservation of of blood blood supply supply Preservation Preservation of of the the blood blood supply supply to to soft soft tissues tissues and and bone bone by by gentle reduction gentle reduction techniques techniques and and careful careful handling. handling. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer-Verlag; 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; Fixation. 3rd ed. Berlin Heidelberg New York: Springer Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme mm Cannulated Screws Surgical Technique DePuy Synthes 3

5 Indications 7.0 mm Cannulated Screws For fracture fixation of large bones and large bone fragments. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. 4 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

6 Surgical Technique Information Cleaning cannulations Instruments Cleaning Brush mm Cleaning Stylet Cleaning the cannulation in each instrument is imperative for proper function. Instruments should be cleared intraoperatively with the 2.0 mm cleaning stylet to prevent accu mu lation of debris in the cannulation and potential binding of the instruments about the guide wire. Instruments should be cleaned post operatively with the stylet and the cleaning brush. Drilling Because of their hollow cross section and long length, cannulated drill bits are more susceptible to breakage than solid drill bits of the same diameter. Use less axial force, avoid bending, and advance the drill bit slowly to minimize the possibility of breakage. Cannulated drill bits should be inspected after every procedure and replaced if worn or damaged. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 5

7 Percutaneous Technique 1 Insert guide wire Instruments mm Trocar mm/ 2.0 mm Drill Sleeve mm/ 4.5 mm Drill Sleeve mm/ 8.0 mm Protection Sleeve Make a stab incision and insert the percutaneous sleeve assembly (11.0 mm/8.0 mm protection sleeve, 8.0 mm/ 4.5 mm and 4.5 mm/2.0 mm drill sleeves, and 2.0 mm trocar) through the soft tissue to the bone. Remove the trocar and insert a 2.0 mm threaded guide wire to the appropriate depth. Confirm wire placement under image intensification. Remove all sleeves. Notes: To prevent slippage, the 4.5 mm/2.0 mm drill sleeve may be tapped with a hammer to seat the teeth in the lateral surface. Run the drill at maximum speed to minimize deflection while gradually advancing the guide wire. 6 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

8 Percutaneous Technique continued 2 Insert additional parallel wires (if necessary) Instruments mm Parallel Drill Guide mm Trocar mm/ 2.0 mm Drill Sleeve Insert one 4.5 mm/2.0 mm drill sleeve into the outer-most 4.5 mm hole of the parallel drill guide. Place this combination over the previously inserted guide wire and push directly to the bone. Insert a second 4.5 mm/2.0 mm drill sleeve and the 2.0 mm trocar into any of the other three holes in the parallel drill guide and press the trocar to the near cortex. Remove the trocar and insert a guide wire through the 4.5 mm/2.0 mm drill sleeve. Insert any additional guide wires following the same procedure and then replace the drill guide with the percutaneous sleeve assembly over one of the guide wires. Notes: Avoid placing any bending forces on the first guide wire, as this will affect parallelism. Any previously inserted guide wire can be used in the outer most hole of the guide for parallel placement of the next guide wire. The placement of three guide wires is recommended to achieve adequate rotational stability. Possible distances between parallel guide wires are 10 mm, 14 mm and 18 mm, measured from the center of the primary hole of the parallel drill guide to the centers of the other holes. Plan placement of each guide wire based on these distances. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 7

9 Percutaneous Technique continued 3 Measure for screw length Instruments Cannulated Screw Measuring Device mm/ 2.0 mm Drill Sleeve Remove the two inner drill sleeves. Slide the tapered end of the cannulated screw measuring device over the guide wire. This reading determines appropriate screw length. Select a 7.0 mm cannulated screw of this length, with a thread which engages only the opposite fragment, and set it aside. Notes: Screw length will be 8 mm short of the guide wire tip (the length of the threaded portion of the wire), preventing penetration of the far cortex. Only use the guide wire in its original length to ensure correct measurement. 8 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

10 Percutaneous Technique continued 4 Predrill Instruments mm Cannulated Drill Bit mm/ 4.5 mm Drill Sleeve Place the 8.0 mm/4.5 mm drill sleeve into the protection sleeve, and drill with the 4.5 mm cannulated drill bit under image intensification to the appropriate depth, being careful not to drill over the guide wire threads and penetrate the far cortex. Remove the 8.0 mm/4.5 mm drill sleeve. Notes: Avoid directing the drill bit; let it follow the guide wire. Take care to remove the drill bit slowly and to pull back straight while running the drill forward to prevent guide wire pullout. Depending on bone quality, the surgeon may choose to drill only the near cortex to prevent inadvertent guide wire pullout. The calibrations on the cannulated drill bits and the cannulated tap are read at the surface of the bone and therefore can not be used when using the percutaneous sleeves. Use image intensification for confirmation of drilling and tapping depths. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 9

11 Percutaneous Technique continued 5 Tap Instruments Cannulated Tap for 7.0 mm Cannulated Screws mm/ 8.0 mm Protection Sleeve Where necessary, tap the near cortex with the cannulated tap through the protection sleeve. In dense bone, it may be necessary to tap over the entire nonthreaded length of the guide wire. 6 Insert screws Instruments Cannulated Hexagonal Screwdriver mm/ 8.0 mm Protection Sleeve Using the cannulated hexagonal screwdriver without the holding sleeve, insert the previously selected screw (Step 3) through the protection sleeve. Remove and discard the guide wire. Note: In osteopenic bone, use a washer to prevent the screw head from sinking into bone. Washers cannot be placed through the percutaneous sleeve. Remove the sleeve before placing the washer over the guide wire. 10 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

12 Open Technique 1 Insert guide wire Instrument Parallel Wire Guide Place a positioning guide wire in the center of the femoral neck. Place the parallel wire guide over the guide wire through one of the central diamond-patterned positioning holes. Notes: The parallel guide s position may be adjusted by replacing it over the guide wire through one of the adjacent positioning holes of the central diamond pattern. The parallel guide does not need to lie flush with the bone. 2 Insert additional parallel wires (if necessary) Instrument Parallel Wire Guide Under image intensification, insert a guide wire to the desired depth through each of the outer triangle-patterned placement holes. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 11

13 Open Technique continued 3 Remove guide wire Remove the parallel guide and the positioning guide wire (inserted in Step 1). 4 Insert screws Measure, drill, tap and insert each screw before proceeding to the next, to prevent loss of reduction. 12 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

14 Implant Removal Instrument Large Hexagonal Screwdriver, for removal of 7.0 mm Cannulated Screws Expose the screw head and remove the screws using the special screwdriver for the removal of cannulated screws. Precaution: Do not use the cannulated screwdriver for implant removal. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 13

15 Implants 7.0 mm Cannulated Screws, 16 mm thread length 30 mm 130 mm lengths in 5 mm increments 316L stainless steel 7.0 mm Cannulated Screws, 32 mm thread length 45 mm 130 mm lengths in 5 mm increments 316L stainless steel Washers, 13.0 mm Prevents screw head from sinking into osteopenic bone 14 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

16 Instruments mm Threaded Guide Wire, 230 mm mm Drill Bit, 100 mm, quick coupling mm Cannulated Drill Bit, 233 mm, Jacobs chuck Cannulated Tap for 7.0 mm Cannulated Screws mm/3.2 mm Double Drill Sleeve Parallel Wire Guide Available nonsterile or sterile-packed. Add S to catalog number for sterile product. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 15

17 Instruments continued Holding Sleeve Cannulated Hexagonal Screwdriver Cannulated Screw Measuring Device mm Cleaning Brush mm Parallel Drill Guide mm Trocar, 118 mm 16 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

18 Instruments continued mm/2.0 mm Drill Sleeve, 108 mm mm/4.5 mm Drill Sleeve, 99 mm mm/8.0 mm Protection Sleeve, 88 mm mm Cleaning Stylet Screw Forceps 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 17

19 7.0 mm Cannulated Screw Instrument and Implant Set (105.07) Graphic Case mm Cannulated Screw Instrument and Implant Set Graphic Case Instruments mm Threaded Guide Wire, 230 mm, 10 ea mm Drill Bit, 100 mm, quick coupling, 2 ea mm Cannulated Drill Bit, 233 mm, Jacobs chuck, 2 ea Cannulated Tap for 7.0 mm Cannulated Screws mm/3.2 mm Double Drill Sleeve Parallel Wire Guide Holding Sleeve Cannulated Hexagonal Screwdriver Cannulated Screw Measuring Device mm Cleaning Brush mm Parallel Drill Guide mm Trocar, 118 mm, 2 ea mm/2.0 mm Drill Sleeve, 108 mm, 2 ea mm/4.5 mm Drill Sleeve, 99 mm mm/8.0 mm Protection Sleeve, 88 mm mm Cleaning Stylet Screw Forceps Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. Available nonsterile or sterile-packed. Add S to catalog number for sterile product. 18 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

20 7.0 mm Cannulated Screw Instrument and Implant Set (105.07) continued Implants 7.0 mm Cannulated Screws, 16 mm thread length Length (mm) Qty mm Cannulated Screws, 32 mm thread length Length (mm) Qty Washer, for 4.5 mm Cortex and 6.5 mm Cancellous Bone Screws, 6 ea. Note: For additional information, please refer to package insert. 7.0 mm Cannulated Screws Surgical Technique DePuy Synthes 19

21 Also Available Small Battery Drive with 14.4 V Battery Pack Sets H with Hudson Reduction Drive Unit M with Modified Trinkle Reduction Drive Unit T with Trinkle Reduction Drive Unit Power Drive Set Instruments mm Threaded Guide Wire, spade point both ends, 230 mm mm Non-Colored Threaded Guide Wire, spade point, 230 mm mm Non-Threaded Guide Wire, spade point one end, 230 mm, blue Cannulated Countersink, for 7.0 mm Cannulated Screws Cannulated 3.5 mm Hexagonal Screwdriver Shaft, for 7.0 mm Cannulated Screws Large Hexagonal Screwdriver, for removal of 7.0 mm Cannulated Screws Screw Rack for 7.0 mm Cannulated Screws, 16 mm and 32 mm Threaded Screw Rack for 7.0 mm Cannulated Screws, fully threaded mm Cannulated Drill Bit, large quick coupling, 90 mm Implants 7.0 mm Cannulated Screws mm thread length, 135 mm 150 mm (5 mm increments) mm thread length, 135 mm 150 mm (5 mm increments) fully threaded, 20 mm 130 mm (5 mm increments) Available nonsterile or sterile-packed. Add S to catalog number for sterile product. 20 DePuy Synthes 7.0 mm Cannulated Screws Surgical Technique

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 fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified 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. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA Synthes USA, LLC 1101 Synthes Avenue Monument, CO To order (USA): To order (Canada): Note: For recognized manufacturer, refer to the product label. DePuy Synthes All rights reserved. DSUS/TRM/0916/1078 2/17 DV