HCS 1.5. The countersinkable compression screw. Surgical Technique This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation.
Table of Contents Introduction HCS 1.5 2 Indications 4 Surgical Technique Surgical Technique for HCS 1.5 5 Screw Extraction 11 Implant Removal 11 Product Information Implants HCS 1.5 12 Instruments HCS 1.5 13 Sets 15 Overview of Product Line HCS 16 MRI Information 17 Image intensifier control 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 HCS 1.5 Surgical Technique DePuy Synthes 1
HCS 1.5. The countersinkable compression screw. Stardrive T4 For optimal torque transmission B 2.2 mm head thread Cutting flutes on screw head Facilitate countersinking of the screw. B 1.2 mm core diameter Identical pitch of head and shaft threads For controlled closure and compression of the fracture gap. Available in steel and titanium All Headless Compression screws from Synthes are available both in stainless implant-grade steel and high-quality biocompatible titanium alloy (TAN). B 1.5 mm shaft thread Self-drilling tip Shorter surgery due to simplified surgical technique. 2 DePuy Synthes HCS 1.5 Surgical Technique
Functional principle: lag screw technique with compression sleeve Step 1: Screw insertion Insert the screw into the bone with the compression sleeve. Step 2: Closure of gap and compression Once the tip of the compression sleeve lies on the bone, the fracture gap is closed and compressed by turning the sleeve. Step 3: Countersinking Once the desired degree of compression is achieved, the screw is countersunk into the bone with the screwdriver while the compression sleeve is held stationary. During countersinking, no additional compression is generated. HCS 1.5 Surgical Technique DePuy Synthes 3
Indications Fixation of intra- and extra-articular fractures and non-unions of small bones and small bone fragments Arthrodesis of small joints Osteochondral fractures Osteotomies Avulsion fractures 4 DePuy Synthes HCS 1.5 Surgical Technique
Surgical Technique for HCS 1.5 1a Predrilling for screw Instruments 310.110 Drill Bit B 1.1 mm, length 60/35 mm, 2-flute, for Quick Coupling 312.140 Double Drill Guide 1.5/1.1 After a stab incision, advance the drill guide through the soft tissues to the bone. Insert the drill bit through the drill guide to the bone and drill to the desired depth. Verify drill depth using the image intensifier. Notes The HCS 1.5 is self-drilling and may be inserted without predrilling. Omitting the predrill step does not allow for accurate length measurement and it may be more difficult to insert the screw in hard cortical bone. Precaution: Avoid forcefully advancing or bending the drill bit as this may cause the drill bit to break. 1b Predrilling for head Instruments 310.509 Drill Bit B 1.8 mm, length 110/85 mm, 2-flute, for Quick Coupling 323.202 Universal Drill Guide 2.4 It is recommended to predrill the near cortex with the drill bit to facilitate head insertion in dense bone and to prevent the bone from cracking. Insert the drill bit in the drill guide and carefully predrill the cortex. HCS 1.5 Surgical Technique DePuy Synthes 5
Surgical Technique for HCS 1.5 2 Determine screw length Instrument 319.003 Depth Gauge for Screws 1.3 to 1.5 mm, measuring range up to 24 mm Measure the screw length using the depth gauge. Note Consider the following when selecting the screw length: Account for fracture gap compression Account for desired countersinking depth Ensure the self-drilling screw tip will not penetrate the far cortex 3 Pick up screw Instruments 03.230.003 Compression Sleeve for HCS Headless Compression Screw B 1.5 mm 319.970 Screw Forceps, self-holding, length 85 mm To remove a screw from the screw rack, twist the compression sleeve over the head thread of the screw or use the screw forceps. 6 DePuy Synthes HCS 1.5 Surgical Technique
The position of the fracture line determines the screw length: Correct screw length The shaft thread lies below the fracture gap and completely within the distal fragment during compression. Fragments can be compressed. Incorrect screw length The shaft thread bridges the fracture gap or the osteotomy. Fragments cannot be compressed. HCS 1.5 Surgical Technique DePuy Synthes 7
Surgical Technique for HCS 1.5 4 Insert screw and compress fragment Instruments 03.226.006 Handle for Compression Sleeve 03.230.003 Compression Sleeve for HCS Headless Compression Screw B 1.5 mm Slide the handle into the compression sleeve. Insert the screw into the bone by turning the compression sleeve until the fracture gap or the osteotomy is closed and compressed. Note: Verify the correct position of the shaft thread in the distal fragment using the image intensifier. If the thread bridges the fracture gap or the osteotomy, the gap cannot be compressed. Precautions: Carefully tighten the screw with the compression sleeve. Forceful tightening could cause stripping of the shaft thread. If the thread strips, some or all of the compression will be lost. If the screw is then countersunk correctly, the thread will regain purchase, thereby reducing the danger of postoperative screw loosening. If loss of compression makes screw extraction necessary, follow the instructions on screw extraction on page 11. 8 DePuy Synthes HCS 1.5 Surgical Technique
5 Countersink screw Instruments 03.230.004 Screwdriver Shaft, Stardrive, T4, with colour marking, for HCS Headless Compression Screw B 1.5 mm 311.430 Handle with Quick Coupling, length 110 mm 03.230.003 Compression Sleeve for HCS Headless Compression Screw B 1.5 mm Remove the handle for compression sleeve from the compression sleeve. Assemble the screwdriver shaft to the handle with quick coupling and slide it through the compression sleeve into the recess of the screw. Countersink the screw by turning the screwdriver shaft while simultaneously holding the compression sleeve stationary. Note: Verify the screw position with the image intensi fier. Ensure that the screw tip does not penetrate the far cortex and that the screw head is properly countersunk. HCS 1.5 Surgical Technique DePuy Synthes 9
Surgical Technique for HCS 1.5 Color markings The color markings on the screwdriver shaft indicate the position of the screwdriver tip and the head thread of the screw in the bone. Green mark flush with the top end of the compression sleeve The screw is fully threaded into the compression sleeve and the screwdriver tip is seated correctly in the recess of the screw. Yellow mark flush with the top end of the compression sleeve The top end of the head thread is even with the bone surface. 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. Red mark flush with the top end of the compression sleeve The top end of the head thread is approximately 1 mm below the bone surface. 11 DePuy Synthes HCS 1.5 Surgical Technique
Screw Extraction Instruments 03.230.004 Screwdriver Shaft, Stardrive, T4, with colour marking, for HCS Headless Compression Screw B 1.5 mm 311.430 Handle with quick coupling, length 110 mm 03.230.003 Compression Sleeve for HCS Headless Compression Screw B 1.5 mm 309.200 Hollow Reamer, complete, anticlockwise cutting, for Screws B 2.0 mm Note: For the extraction of the HCS 1.5 use the Screwdriver Shaft in combination with the handle with quick coupling. Note: If the screw strips, use the following procedure: Thread the compression sleeve over the screw head thread. Insert the screwdriver through the compression sleeve into the recess of the screw. Remove the screw by simultaneously pulling on the compression sleeve and turning both the screwdriver and the compression sleeve in counterclockwise direction. Note: If necessary, expose the recess and part of the head thread with a hollow reamer (e.g. 309.200) or use another preferred method. Implant Removal In case the physician decides to remove the implants, implants can be removed by using general surgical instruments. In case of difficult removal circumstances, a Screw Extraction Set is available with corresponding instructions (036.000.917). HCS 1.5 Surgical Technique DePuy Synthes 11
Implants HCS 1.5 HCS 1.5 Headless Compression Screw, self-drilling Art. No. Screw Shaft thread length (mm) length (mm) L S S L 1 mm 0X.230.108 8 4 0X.230.109 9 4 0X.230.110 10 4 0X.230.111 11 4 0X.230.112 12 4 0X.230.113 13 4 0X.230.114 14 4 0X.230.115 15 4 0X.230.116 16 5 0X.230.117 17 5 0X.230.118 18 5 0X.230.119 19 5 0X.230.120 20 6 X = 2: Stainless Steel X = 4: Titanium Alloy (TAN) All implants are also available sterile packed. Add suffix S to article number. 11 DePuy Synthes HCS 1.5 Surgical Technique
Instruments HCS 1.5 03.230.003 Compression Sleeve for HCS Headless Compression Screw B 1.5 mm 03.230.004 Screwdriver Shaft, Stardrive, T4, with colour marking, for HCS Headless Compression Screw B 1.5 mm 03.226.006 Handle for Compression Sleeve, for HCS Headless Compression Screw 311.430 Handle with Quick Coupling, length 110 mm 319.970 Screw Forceps, self-holding, length 85 mm 312.140 Double Drill Guide 1.5/1.1 323.202 Universal Drill Guide 2.4 310.110 Drill Bit B 1.1 mm, length 60/35 mm, 2-flute, for Quick Coupling HCS 1.5 Surgical Technique DePuy Synthes 13
Instruments HCS 1.5 319.003 Depth Gauge for Screws B 1.3 to 1.5 mm, measuring range up to 24 mm 310.509 Drill Bit B 1.8 mm, with marking, length 1110/85 mm, 2-flute, for Quick Coupling 14 DePuy Synthes HCS 1.5 Surgical Technique
Sets 01.230.002 Instrument and Implant Set for HCS Headless Compression Screw B 1.5 mm (Stainless Steel) for Vario Case 01.230.004 Instrument and Implant Set for HCS Headless Compression Screw B 1.5 mm (Titanium Alloy) for Vario Case HCS 1.5 Surgical Technique DePuy Synthes 11
Overview of Product Line HCS Thread B Material Thread length Screw length Guide wire B 1.5 mm Stainless Steel/TAN Variable (4 6 mm) 8 20 mm Not cannulated 2.4 mm Stainless Steel/TAN Short thread (variable) 9 20 mm 1.1 mm 2.4 mm Stainless Steel/TAN Long thread (variable) 16 40 mm 1.1 mm 3.0 mm Stainless Steel/TAN Short thread (variable) 10 40 mm 1.1 mm 3.0 mm Stainless Steel/TAN Long thread (variable) 16 40 mm 1.1 mm 4.5 mm Stainless Steel/TAN Short thread (variable) 20 110 mm 2.8 mm 4.5 mm Stainless Steel/TAN Long thread (variable) 30 110 mm 2.8 mm 6.5 mm Stainless Steel/TAN Short thread (variable) 30 150 mm 2.8 mm 6.5 mm Stainless Steel/TAN Long thread (variable) 45 150 mm 2.8 mm 11 DePuy Synthes HCS 1.5 Surgical Technique
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 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 thermoregulation 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 specific absorption rate (SAR) should be reduced as far as possible. Using the ventilation system may further contribute to reduce temperature increase in the body. HCS 1.5 Surgical Technique DePuy Synthes 11
DSEM/TRM/0815/0484(2) 12/15 Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 Fax: +41 61 965 66 00 www.depuysynthes.com Not all products are currently available in all markets. This publication is not intended for distribution in the USA. All surgical techniques are available as PDF files at www.depuysynthes.com/ifu 0123 DePuy Synthes Trauma, a division of Synthes GmbH. 2015. All rights reserved. 036.000.078