2.4 mm and 3.0 mm Headless Compression Screws

Transcription

1 For Fixation of Small Bones and Small Bone Fragments 2.4 mm and 3.0 mm Headless s Surgical Technique

2 Table of Contents Introduction 2.4 mm and 3.0 mm Headless 2 Technique Overview 4 AO Principles 5 Indications 6 Surgical Technique Scaphoid Fixation 7 First Metatarsal Osteotomy 14 Screw Removal 20 Product Information Implants 21 Instruments 25 Set Lists 28 MR Information The Headless s 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 Headless s System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Image intensifier control 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 1

3 The 2.4 mm Self-Drilling, Self-Tapping, Cannulated Headless 1.1 mm guide wire T8 StarDrive TM Recess 3.1 mm cortical thread (double thread*) Self-drilling and self-tapping flutes 2.0 mm shaft Implant quality 316L stainless steel Titanium alloy Ti-6Al-7Nb 2.4 mm cancellous thread (single thread*) Long thread Short thread Self-drilling and self-tapping flutes * Threads are of equal lead (i.e. they advance the same distance for each revolution) 2 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

4 The 3.0 mm Self-Drilling, Self-Tapping, Cannulated Headless 1.1 mm guide wire T8 StarDrive Recess 3.5 mm cortical thread (double thread*) Self-drilling and self-tapping flutes 2.0 mm shaft Implant quality 316L stainless steel Titanium alloy Ti-6Al-7Nb 3.0 mm cancellous thread (single thread*) Long thread Short thread Self-drilling and self-tapping flutes * Threads are of equal lead (i.e. they advance the same distance for each revolution) 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 3

5 Technique Overview 1 Insert screw Thread the head of the headless compression screw into the tip of the compression sleeve. Insert the screw into the bone using the compression sleeve construct. 2 Compress The tip of the compression sleeve acts as a conventional lag screw head. When the tip of the compression sleeve contacts the bone, the fracture gap is closed and compressed as with a lag screw. 3 Countersink Following compression of the fracture, hold the compression sleeve stationary and use the screwdriver to advance the screw head into the bone. 4 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

6 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 and 3.0 mm Headless s Surgical Technique DePuy Synthes 5

7 Indications Synthes 2.4 mm Headless s are indicated for fixation of fractures and nonunions of small bones and small bone arthrodeses, including scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid. Synthes 3.0 mm Headless s are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. Scaphoid nonunion Scaphoid fracture Carpal fusion DIP fusion Calcaneal and talar fractures Bunionectomy Toe fusion Radial styloid fracture 6 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

8 Scaphoid Fixation This surgical technique describes a volar approach procedure. Depending on the type and location of the fracture, a dorsal approach to the scaphoid may be preferred. The same surgical steps apply. 1 Insert guide wire Instruments , 1.1 mm Guide Wire (threaded or nonthreaded) mm/ 1.1 mm Double Drill Sleeve Reduce fragments with a 1.1 mm guide wire and the 2.0 mm/1.1 mm double drill sleeve using image intensification. Insert the wire from distal-radial to proximal-ulnar until the tip is anchored into the far cortex. Ensure the guide wire lies along the central axis of the scaphoid in the frontal and sagittal planes. Note: Using a pen-style rather than a pistol-grip drive unit may facilitate the insertion of the 1.1 mm guide wire. Insert the guide wire in 10 mm to 15 mm increments to minimize the possibility of bending the wire. Precaution: Do not forcefully insert the guide wire. This may cause it to bend. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 7

9 Scaphoid Fixation 2 Drill trapezium (optional) Instruments mm Cannulated Trapezium Drill mm Trapezium Drill Sleeve Handle, with quick coupling If the foot process of the trapezium is prominent, it can be removed with the 4.8 mm cannulated trapezium drill to ensure central placement of the screw. Slide the trapezium drill through the 4.8 mm trapezium drill sleeve and over the guide wire to the trapezium. Carefully drill the trapezium by hand to remove interfering bone. Use image intensification to ensure the trapezium drill does not damage the scaphoid. Note: Do not forcefully insert the trapezium burr since this may damage the guide wire. 8 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

10 Scaphoid Fixation 3 Measure screw length Instrument Measuring Device Slide the tapered end of the measuring device over the guide wire to the bone. The reading on the measuring device at the end of the guide wire indicates the screw length which will place the screw tip at the tip of the guide wire. To choose the appropriate screw length, subtract approximately 2 mm to account for fracture gap compression and the desired countersinking depth. When selecting the shaft thread length, ensure that all threads are past the fracture line during the compression stage. Note: Only use the guide wire in its original length to ensure correct measurement. Correctly selected thread length Shaft thread is past the fracture line during compression. Note: If there is no good bone quality in the distal part of the bone, the distal screw thread can strip-out if too much compression is applied. Incorrect thread length Shaft thread is in the fracture gap. Compression of the fracture gap is not possible. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 9

11 Scaphoid Fixation 4 Drill (optional) Instruments mm Cannulated Drill Bit mm/ 1.1 mm Double Drill Sleeve The self-drilling flutes of the headless compression screw make predrilling unnecessary in most cases. Predrilling is recommended in dense bone and in arthrodeses, as the axial force necessary for inserting self-drilling screws could temporarily distract the fragments. Place the 2.0 mm/1.1 mm double drill sleeve with the 2.0 mm cannulated drill bit over the guide wire. Drill, using image intensification if necessary. Note: To prevent the guide wire from backing out during drilling, do not over-drill at the tip of the wire, and remove the drill bit slowly. To ensure the guide wire stays in place, do not use the drill in reverse. Before drilling and after measuring, the wire may be advanced into the distal radius to assure retention after drilling. Precaution: Avoid forcefully advancing or bending the drill bit as this may cause the drill bit to break. Do not advance the drill bit beyond the wire. When drilling is complete, slowly pull the drill bit straight out while running the power tool in forward mode to ensure the guide wire stays in place. 11 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

12 Scaphoid Fixation 5 Pick up screw Instruments Compression Sleeve for 3.0 mm Headless Compression Sleeve for 2.4 mm Headless Twist the compression sleeve over the head thread of the screw to remove it from the screw rack. Optional instrument Screw Forceps Alternatively, use the screw forceps to pick up the screw from the rack and thread it into the compression sleeve. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 11

13 Scaphoid Fixation 6 Insert screw and compress Instruments Compression Sleeve for 3.0 mm Headless Compression Sleeve Handle Compression Sleeve for 2.4 mm Headless Slide the compression sleeve handle into the back of the compression sleeve. Insert the screw over the guide wire and thread it into the bone by turning the compression sleeve. Tighten the compression sleeve until the fracture gap is closed and compressed. Precaution: Take care not to over-tighten the screw as the threads may strip. Use a two-finger technique to tighten the screw. If the thread strips (noticeable through decreased resistance while tightening), some of the compression will be lost. When the screw is countersunk, the thread will purchase the bone again, thus reducing the danger of postoperative screw loosening. If loss of compression makes screw removal necessary, follow the instructions on page 20. Note: Use image intensification to check that the entire shaft thread is beyond the fracture line. Otherwise no compression can be achieved. 11 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

14 Scaphoid Fixation 7 Insert screw head Instruments Compression Sleeve for 3.0 mm Headless Cannulated StarDrive Screwdriver Shaft, T8, quick coupling Hold Compression Sleeve for 2.4 mm Headless Hold Handle, with quick coupling Remove the compression sleeve handle from the compression sleeve. Slide the cannulated StarDrive Screwdriver shaft through the compression sleeve into the recess of the screw. Implant the head thread by turning the screwdriver clockwise. Hold the compression sleeve stable to prevent rotation, while slightly pressing the compression sleeve on the bone. Color markings The color markings on the screwdriver shaft indicate the position of the screw in the bone: n When the green mark is flush with the top of the compression sleeve, the screw is fully threaded into the compression sleeve and the screwdriver tip is seated in the recess of the screw n When the yellow mark is flush with the top of the compression sleeve, the top of the screw is flush with the bone surface n When the red mark is flush with the top of the compression sleeve, the screw is 2 mm below the bone surface Check final screw position with image intensification. Remove and discard the guide wire. Note: If the screw is inserted at an angle, it must be countersunk further than the yellow mark so that it does not project from the surface. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 11

15 First Metatarsal Osteotomy The following is a simplified description of the first metatarsal osteotomy (Austin Osteotomy). It is an example to illustrate a use of the headless compression screw in the foot. 1 Perform osteotomy Remove the bunion on the medial side of the first metatarsal, and perform a chevron osteotomy with a saw blade. 2 Move distal fragment Slide the distal fragment in the lateral direction. 11 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

16 First Metatarsal Osteotomy 3 Insert guide wire Instruments , 1.1 mm Guide Wire (threaded or nonthreaded) mm/ 1.1 mm Double Drill Sleeve While monitoring with the image intensifier, advance the 1.1 mm guide wire through the 2.0 mm/1.1 mm double drill sleeve from proximal-dorsal to distal-plantar through the osteotomy, until the thread tip is anchored in the far cortex. Precaution: Do not forcefully insert the guide wire. This may cause it to bend. 4 Measure screw length Instrument Measuring Device Slide the tapered end of the measuring device over the guide wire to the bone. The reading on the measuring device at the end of the guide wire indicates the screw length which will place the screw tip at the tip of the guide wire. To choose the appropriate screw length, subtract approximately 2 mm to account for osteotomy gap compression and the desired countersinking depth. When selecting the shaft thread length, ensure that all threads will be past the osteotomy line during the compression stage. Note: The position of the osteotomy line determines the thread length. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 11

17 First Metatarsal Osteotomy 5 Drill (optional) Instruments mm Cannulated Drill Bit mm/ 1.1 Double Drill Sleeve The self-drilling flutes of the headless compression screw make predrilling unnecessary in most cases. However, predrilling is recommended in dense bone and in arthrodeses, as the axial force necessary for inserting self-drilling screws could temporarily distract the fragments. Place the 2.0 mm/1.1 mm double drill sleeve and the 2.0 mm cannulated drill bit over the guide wire. Drill, using image intensification if necessary. Precaution: Avoid forcefully advancing or bending the drill bit as this may cause the drill bit to break. Do not advance the drill bit beyond the wire. When drilling is complete, slowly pull the drill bit straight out while running the power tool in forward mode to ensure the guide wire stays in place. 6 Pick up screw Instruments Compression Sleeve for 3.0 mm Headless Compression Sleeve for 2.4 mm Headless Twist the compression sleeve over the head thread of the screw to remove it from the screw rack. Optional instrument Screw Forceps Alternatively, use the screw forceps to pick up the screw from the rack and thread it into the compression sleeve. 11 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

18 First Metatarsal Osteotomy 7 Insert screw and compress Instruments Compression Sleeve for 3.0 mm Headless Compression Sleeve Handle Compression Sleeve for 2.4 mm Headless Slide the compression sleeve handle into the back of the compression sleeve. Insert the screw over the guide wire and thread into the bone by turning the compression sleeve. Tighten the compression sleeve until the osteotomy is compressed. Precaution: Take care not to over-tighten the screw as the threads may strip. Use a two-finger technique to tighten the screw. If the thread strips (noticeable through decreased resistance while tightening), some of the compression will be lost. When the screw is countersunk, the thread will purchase the bone again, thus reducing the danger of postoperative screw loosening. If loss of compression makes screw removal necessary, follow the instructions on page 20. Note: Use image intensification to check that the shaft thread is beyond, and not across, the osteotomy site. Otherwise no compression can be achieved. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 11

19 First Metatarsal Osteotomy 8 Insert screw head Instruments Compression Sleeve for 3.0 mm Headless Cannulated StarDrive Screwdriver Shaft, T8, quick coupling Compression Sleeve for 2.4 mm Headless Handle, with quick coupling Remove the compression sleeve handle from the compression sleeve. Slide the cannulated StarDrive Screwdriver shaft through the compression sleeve into the recess of the screw. Implant the head thread by turning the screwdriver clockwise. Hold the compression sleeve stable to prevent rotation, while slightly pressing the compression sleeve on the bone. Color markings The color markings on the screwdriver shaft indicate the position of the screw in the bone: n When the green mark is flush with the top of the compression sleeve, the screw is fully threaded into the compression sleeve and the screwdriver tip is seated in the recess of the screw n When the yellow mark is flush with the top of the compression sleeve, the top of the screw is flush with the bone surface n When the red mark is flush with the top of the compression sleeve, the screw is 2 mm below the bone surface Check final screw position with image intensification. Remove and discard the guide wire. Note: If the screw is inserted at an angle, it must be countersunk further than the yellow mark so that it does not project from the surface. 11 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

20 First Metatarsal Osteotomy 9 Remove protruding bone Remove the projecting bone of the proximal fragment with a saw blade. 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 11

21 Screw Removal Instruments Compression Sleeve for 3.0 mm Headless Cannulated StarDrive Screwdriver Shaft, T Compression Sleeve for 2.4 mm Headless Handle, with quick coupling StarDrive Screwdriver Shaft, T8 To remove the headless compression screw, use a T8 StarDrive Screwdriver shaft. If the screw threads are stripped, however, use the following procedure: Twist the compression sleeve over the head thread, and insert the screwdriver through the compression sleeve into the StarDrive Recess of the screw. If necessary, expose the StarDrive Recess and part of the head thread using a hook, hollow reamer, or curette. Remove the screw by simultaneously pulling on the compression sleeve and turning the screwdriver counterclockwise. Note: If necessary, expose the recess and part of the head thread with a hollow reamer or preferred method. 22 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

22 Implants 2.4 mm Headless s, short thread Shaft thread (T) approximately 20% of screw length (L) Stainless Length Thread Steel Titanium (mm) length (mm) T L 2 mm 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 22

23 Implants 2.4 mm Headless s, long thread Shaft thread (T) approximately 40% of screw length (L) Stainless Length Thread Steel Titanium (mm) length (mm) T L 2 mm 22 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

24 Implants 3.0 mm Headless s, short thread Shaft thread (T) approximately 20% of screw length (L) Stainless Length Thread Steel Titanium (mm) length (mm) T L 2 mm 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 22

25 Implants 3.0 mm Headless s, long thread Shaft thread (T) approximately 40% of screw length (L) Stainless Length Thread Steel Titanium (mm) length (mm) T L 2 mm 22 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

26 Instruments Compression Sleeve for 3.0 mm Headless Measuring Device mm Cannulated Trapezium Drill, quick coupling Cannulated StarDrive Screwdriver Shaft, T8, quick coupling mm Trapezium Drill Sleeve Compression Sleeve Handle Compression Sleeve for 2.4 mm Headless 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 22

27 Instruments mm Threaded Guide Wire, 150 mm length mm Nonthreaded Guide Wire, 150 mm length mm Cannulated Drill Bit, quick coupling, 150 mm Handle, with quick coupling mm/1.1 mm Double Drill Sleeve StarDrive Screwdriver Shaft, T mm Cleaning Brush 22 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

28 Instruments mm Cleaning Stylet Screw Forceps Freer Elevator Scaphoid Elevator Also Available mm Drill Guide with Stop Measuring Device for Drill Guide with Stop 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 22

29 2.4 mm Headless Sets Stainless Steel ( ) and Titanium ( ) Screw Rack Screw Rack for 2.4 mm Headless s (with lid) Implants in set mm Headless s, short thread, 9 mm 40 mm, 2 ea mm Headless s, long thread, 17 mm 40 mm, 2 ea. Implants in set mm Titanium Headless Compression Screws, short thread, 9 mm 40 mm, 2 ea mm Titanium Headless Compression Screws, long thread, 17 mm 40 mm, 2 ea. Compression sleeve fits here Also Available Lid for Screw Rack for 2.4 mm Headless Compression Sleeve for 2.4 mm Headless 22 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

30 3.0 mm Headless Sets Stainless Steel ( ) and Titanium ( ) Screw Rack Screw Rack for 3.0 mm Headless s (with lid) Implants in set mm Headless s, short thread, 10 mm 40 mm, 2 ea mm Headless s, long thread, 16 mm 40 mm, 2 ea. Implants in set mm Titanium Headless Compression Screws, short thread, 10 mm 40 mm, 2 ea mm Titanium Headless Compression Screws, long thread, 16 mm 40 mm, 2 ea. Also Available Lid for Screw Rack for 3.0 mm Headless s 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 22

31 2.4 mm and 3.0 mm Headless Instrument Set ( ) Graphic Case mm and 3.0 mm Headless Compression Screw Graphic Case Instruments Compression Sleeve for 3.0 mm Headless Measuring Device mm Cannulated Trapezium Drill Cannulated StarDrive Screwdriver Shaft, T8, 2 ea mm Trapezium Drill Sleeve Compression Sleeve Handle Compression Sleeve for 2.4 mm Headless mm Threaded Guide Wire, 150 mm, 10 ea mm Nonthreaded Guide Wire, 150 mm, 10 ea mm Cannulated Drill Bit, quick coupling, 150 mm, 2 ea Handle, with quick coupling mm/ 1.1 mm Double Drill Sleeve StarDrive Screwdriver Shaft, T mm Cleaning Brush mm Cleaning Stylet Screw Forceps Freer Elevator Scaphoid Elevator Also Available mm Drill Guide with Stop Measuring Device for Drill Guide with Stop Screw Rack for 3.0 mm Headless (with lid) mm and 3.0 mm Headless Compression Screw Graphic Case Lid Screw Rack for 2.4 Headless Compression Screw (with lid) Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or sterilization instructions, if provided. 33 DePuy Synthes 2.4 mm and 3.0 mm Headless s Surgical Technique

32 2.4 mm and 3.0 mm Headless Instrument and Implant Sets Stainless Steel ( ) and Titanium ( ) mm and 3.0 mm Headless Compression Screw Instrument and Implant Set Set consists of: mm Headless Implant Set mm Headless Implant Set mm and 3.0 mm Headless Compression Screw Instrument Set mm and 3.0 mm Headless Compression Screw Instrument and Titanium Implant Set Set consists of: mm Headless Titanium Implant Set mm Headless Titanium Implant Set mm and 3.0 mm Headless Compression Screw Instrument Set 2.4 mm and 3.0 mm Headless s Surgical Technique DePuy Synthes 33

33 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/0916/1087 5/17 DV