0x6.001.067_AB 15.11.12 07:00 Seite Cvr1 DLS Dynamic Locking Screw. Combined with LCP Locking Compression Plate. Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite Cvr2 0x6.001.067_AB 15.11.12 07:00 Seite 1 Table of Contents Introduction Instructions for Use Product Information DLS Dynamic Locking Screw 2 Indications 5 Dynamic Locking Screw Technique 6 Compatibility with the LCP Percutaneous Instrument System 3.5 13 Implant Removal 14 Technical Information 15 Implants 16 Instruments for DLS 3.7 mm 18 Instruments for DLS 5.0 mm 20 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please refer to: www.synthes.com/reprocessing Dynamic Locking Screw Instructions for Use Synthes 1 0x6.001.067_AB 15.11.12 07:00 Seite 2 DLS Dynamic Locking Screw. Combined with LCP Locking Compression Plate. DLS Dynamic Locking Screw Stardrive recess. For better torque transmission. Angular stable screw Locking screws can be placed in each threaded hole of the appropriate LCP. Screws lock tightly in the plate to: – eliminate tension on the bone – eliminate compression between plate and bone – protect periosteum from potential damage and retain circulation Pin-sleeve design of the DLS allows micro-motion within the angular stable system. DLS can be used with all Synthes’ titanium or stainless steel locking plates. Cobalt chromium molybdenum alloy (CoCrMo) enables DLS to be as strong as standard locking screws. CoCrMo encourages less ingrowth and facilitates screw removal – similar to stainless steel screws. Laserwelded. For stable fixation between pin and sleeve. 2 Synthes Dynamic Locking Screw Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 3 Principle of Dynamic Locking Screw (DLS) Standard locking head. Compatible with all Synthes’ locking plates. DLS allows surgeons to modulate the rigidity of the locked plate construct for better load distribution. Pin-sleeve design. Micro-motion within the screw. DLS construct can deliver nearly parallel fracture site motion. Standard thread in the shaft. For strong anchorage in bone. Boosting biological bone healing: Micro-motions on the plate-side of the locking construct improve circumferential callus formation. New screw tip. Rounded tip and five flute design. Dynamic Locking Screw Instructions for Use Synthes 3 0x6.001.067_AB 15.11.12 07:00 Seite 4 LCP Locking Compression Plate – Provides angular stable support of fragments regardless of bone quality – Reduces risk of primary and secondary loss of reduction even under high dynamic loading – Reduces impairment of periosteal blood supply due to limited plateperiosteum contact – Maintains favorable hold in osteoporotic bone and multiple fragment fractures LCP combi-hole A B DLS – Self-tapping dynamic locking screw – Requires precise measurement of length (diaphysis and metaphysis) – Bicortical use in the shaft – Not necessary to separately tap thread 4 Synthes Dynamic Locking Screw A. Stable plate-screw connection – Locking screws reduce screw loosening – Excessive torque is not applied to the cortical bone – The conical screw head facilitates screw insertion B. Compatibility – The proven dynamic compression hole allows for use of all standard screws Standard screw – Dynamic compression is created by the eccentric insertion of the standard screw (analogous to LC-DCP) Self-tapping locking screw – Requires precise measurement of length (metaphysis) – Monocortical or bicortical use – Not necessary to separately tap thread Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 5 Indications Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for the fixation of metaphyseal and diaphyseal shaft fractures of long bones (humerus, femur and tibia). The DLS allows micro-motion within the angular stable system. Synthes offers a wide selection of LCP plates, which covers a correspondingly extensive variety of indications. For this reason, this technical guide does not cover specific indications or the selection of a plate type for specific clinical situations. For treatment of these subjects, please refer to ”AO Principles of Fracture Management,” courses offered by the AO (www.aofoundation.org), and the corresponding professional literature. For general purposes, the following techniques for handling the implants and instruments will be demonstrated with a straight 3.5 mm LCP and DLS 3.7 mm. Important: The DLS 3.7 mm has a 0.2 mm larger shaft thread diameter compared to the standard locking screw 3.5 mm. Therefore dedicated instruments for DLS 3.7 mm (drill bit and drill sleeve) have to be used. The other instruments stay the same. Standard locking screw 5.0 instrumentation can be used for the DLS 5.0 (see pages 19 and 20). Dynamic Locking Screw Instructions for Use Synthes 5 0x6.001.067_AB 15.11.12 07:00 Seite 6 Dynamic Locking Screw Technique 1 Reduce and fix fracture Reduce the fracture under image intensification. As needed, provide fixation with a Kirschner wire or reduction forceps. 2 Bend plate Instruments 329.040 Bending Iron for Plates 2.4 to 3.5 length 145 mm (for use with 329.050) 329.050 Bending Iron for Plates 2.4 to 3.5 length 145 mm (for use with 329.040) 329.150 Bending Pliers for Plates 2.4 to 4.0, length 230 mm 329.290 Bending Pliers for Reconstruction Plates 2.7 and 3.5 Adapt the LCP plate to the anatomy using the appropriate bending instruments (as for standard plates), especially in the case of joint fractures. Notes – Do not bend the plate back and forth. – The LCP combi-holes are asymmetrical in the plate. In straight plates, the hole alignment changes in the middle of the plate. This asymmetry enables exertion of unidirectional dynamic compression. 6 Synthes Dynamic Locking Screw Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 7 3 Position and fix plate Position and fix the plate on the bone. Important: Before setting the first dynamic locking screw, ensure that the plate is provisionally well fixed in place. Otherwise the plate may rotate during screw locking, causing damage to surrounding soft tissue. Dynamic Locking Screw Instructions for Use Synthes 7 0x6.001.067_AB 15.11.12 07:00 Seite 8 Dynamic Locking Screw Technique 4 Prepare DLS drill sleeve Instrument 03.213.001 DLS Drill Sleeve 3.7, for Drill Bits ⭋ 3.1 mm Carefully screw the DLS drill sleeve into the desired LCP hole until it is gripped completely by the thread. The DLS drill sleeve ensures that the dynamic locking screw is correctly locked in the plate. Angular stability is reduced if a locking screw is inserted obliquely. Technique tip: To make it easier for the drill sleeve to locate the start of the thread, it may be useful to slightly rotate the drill sleeve counterclockwise. Note: In precontoured plates, the threaded holes might not be perpendicular to the plate surface due to the anatomy. Important: Only use the white color-coded DLS drill sleeve with the white color coded drill bit for DLS 3.7 mm. For the DLS 5.0 mm the standard drill sleeve and drill bit as for standard locking screws can be used. 8 Synthes Dynamic Locking Screw Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 9 5 Predrill screw hole and determine screw length Instrument 03.213.002 DLS Drill Bit ⭋ 3.1 mm with Stop, length 165 mm, 2-flute, for Quick Coupling Carefully drill the screw hole using an appropriate drill bit. Remove the drill sleeve. Important: Only use the white color-coded DLS drill bit for DLS 3.7 mm to ensure the correctly sized drill hole. Example showing measured length of 24 mm. 6 Option: Determine screw length Instrument 319.010 Depth Gauge Determine the screw length with the depth gauge. Example showing measured length of 24 mm. Dynamic Locking Screw Instructions for Use Synthes 9 0x6.001.067_AB 15.11.12 07:00 Seite 10 Dynamic Locking Screw Technique 7 Insert Dynamic Locking Screw Instruments 511.770 Torque Limiter, 1.5 Nm 511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling 314.116 Screwdriver Shaft T15, self-holding 397.705 Handle for Torque Limiter Nos. 511.770 and 511.771 311.431 Handle with Quick Coupling Before insertion of the first dynamic locking screw, anatomical reconstruction must have occurred. After insertion of the dynamic locking screws, additional reduction cannot be achieved without removing the dynamic locking screws. The dynamic locking screws can either be inserted with a power tool (without final locking) or manually and always with a torque limiter. Important – Always insert the dynamic locking screw with the dedicated torque limiter. – 3 or more dynamic locking screws must be inserted for each segment / fragment. – Do not combine standard locking screws and/or standard screws with DLS in the same segment/fragment. This will nullify the dynamization and might overload the standard locking screw; however, one fragment can be fixed with a standard locking screw and another with DLS. Note: Do not press the plate onto the bone. This will nullify the dynamization. 10 Synthes Dynamic Locking Screw Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 11 7a Insertion with power tool To insert the dynamic locking screw using a power tool, fit a torque limiter to the power tool. Then insert the screwdriver shaft into the torque limiter. Pick up the dynamic locking screw and insert it into the plate hole. To insert the screw, start the power tool slowly, increasing the speed and then reducing it again before the dynamic locking screw is fully tightened. Uncouple the power tool and mount the handle for torque limiter or the handle with quick coupling and manually tighten the screw. After one click, the optimum torque is reached. Notes – To reduce the risk of stripping the screw head, do not lock dynamic locking screws at full speed. Screw head stripping can cause difficulty in removing the implant. – For long screws and thick cortical bone, ensure sufficient cooling during insertion. Important: Always insert the dynamic locking screw with the dedicated torque limiter: DLS 3.7 mm → TLA 1.5 Nm DLS 5.0 mm → TLA 4.0 Nm Dynamic Locking Screw Instructions for Use Synthes 11 0x6.001.067_AB 15.11.12 07:00 Seite 12 Dynamic Locking Screw Technique 7b Manual insertion To insert the dynamic locking screw manually, attach the torque limiter handle to the torque limiter and insert a screwdriver shaft. Screw in the dynamic locking screw, and lock it in the plate. Important – Always insert and lock the dynamic locking screw with the dedicated torque limiter: DLS 3.7mm → TLA 1.5 Nm DLS 5.0mm → TLA 4.0 Nm – The dynamic locking screw is only available with Stardrive recess and should only be used with the appropriate Stardrive screwdriver. Do not use the hexagonal screwdriver. Note: Under image intensification you can identify the pinsleeve design of the DLS. 12 Synthes Dynamic Locking Screw Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 13 Compatibility with the LCP Percutaneous Instrument System 3.5 mm The LCP Percutaneous Instrument Set 3.5 mm consists of a comprehensive series of aiming arms and instrumentation to facilitate the percutaneous, submuscular insertion of various plates. The DLS 3.7 mm is compatible with the LCP Percutaneous Instrument System 3.5 mm. For the use of the DLS 3.7 with LCP Percutaneous Instrument System 3.5 the LCP Small Fragment Percutaneous Instrument Set 3.5 needs to be upgraded with the following instruments: 03.113.030 Drill Bit ⭋ 3.1 mm with Stop, calibrated, length 250/225 mm, for Quick Coupling 03.113.031 Locking Drill Sleeve ⭋ 3.1 mm, percutaneous For the complete instruction and technique details of the use of the LCP Percutaneous Instrument System 3.5 please refer to technique guide “LCP Low Bend Medial Distal Tibia Plate Aiming Instruments 3.5 mm” 036.001.045 and “LCP Percutaneous Aiming System 3.5 for PHILOS” 036.001.024. Dynamic Locking Screw Instructions for Use Synthes 13 0x6.001.067_AB 15.11.12 07:00 Seite 14 Implant Removal To remove the plate, first remove tissue and bone from all screw heads and drives. Insert a screwdriver in the screw recess and unlock all screws manually. Then completely remove all screws. If the screws cannot be removed with the screwdriver, consult the separate Synthes publication “Screw Extraction Set: Instruments for removing Synthes screws” (Art. No. 036.000.918: pages 27–31 (Situation B) and pages 44 – 47), which explains how broken screws can be removed. These are the specific instruments for the extraction of the dynamic locking screws: DLS 3.7 mm: 309.035 Hollow Reamer, complete, anticlockwise cutting, for Screws ⭋ 3.5 and 4.0 mm 309.038 Spare Reamer Tube, for No. 309.035 309.039 Extraction Bolt, for Screws ⭋ 3.5 and 4.0 mm 309.510 Extraction Screw, conical, for Screws ⭋ 1.5 and 2.0 mm 309.520 Extraction Screw, conical, for Screws ⭋ 2.7, 3.5 and 4.0 mm DLS 5.0 mm: 309.450 Hollow Reamer, complete, anticlockwise cutting, for Screws ⭋ 4.5 mm 309.480 Spare Reamer Tube, for No. 309.450 309.490 Extraction Bolt, for Screws ⭋ 4.5 and 5.0 mm 309.520 Extraction Screw, conical, for Screws ⭋ 2.7, 3.5 and 4.0 mm 309.521 Extraction Screw for Screws ⭋ 3.5 mm 14 Dynamic Locking Screw Synthes Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 15 Technical Information Screw and pin lengths * 38 – 90 mm Long Pin * 32 – 36 mm * DLS 5.0 The three shortest screws (32 – 36 mm) have a shorter pin, and all longer screws (38 – 90 mm) have the same longer length pin. The result is a comparable elastic behavior across all screw lengths. Short Pin * 26 – 70 mm Long Pin * 22 and 24 mm Short Pin DLS 3.7 The two shortest screws (22 and 24 mm) have a shorter pin, and all longer screws (26 – 70 mm) have the same longer length pin. The result is a comparable elastic behavior across all screw lengths. * * Maximum deflection 0.2 mm * Maximum deflection 0.35 mm Dynamic Locking Screw Instructions for Use Synthes 15 0x6.001.067_AB 15.11.12 07:00 Seite 16 Implants DLS 3.7 – Dynamic Locking Screw ⭋ 3.7 mm, self-tapping – CoCrMo – Sterile Art no. Length (mm) 09.213.022S 22 09.213.024S 24 09.213.026S 26 09.213.028S 28 09.213.030S 30 09.213.032S 32 09.213.034S 34 09.213.036S 36 09.213.038S 38 09.213.040S 40 09.213.042S 42 09.213.044S 44 09.213.046S 46 09.213.048S 48 09.213.050S 50 09.213.052S 52 09.213.054S 54 09.213.055S 55 09.213.056S 56 09.213.058S 58 09.213.060S 60 09.213.065S 65 09.213.070S 70 Warning: Do not resterilize the Dynamic Locking Screw. 16 Synthes Dynamic Locking Screw Instructions for Use 0x6.001.067_AB 15.11.12 07:00 Seite 17 DLS 5.0 – Dynamic Locking Screw ⭋ 5.0 mm, self-tapping – CoCrMo – Sterile Art no. Length (mm) 09.223.032S 32 09.223.034S 34 09.223.036S 36 09.223.038S 38 09.223.040S 40 09.223.042S 42 09.223.044S 44 09.223.046S 46 09.223.048S 48 09.223.050S 50 09.223.055S 55 09.223.060S 60 09.223.065S 65 09.223.070S 70 09.223.075S 75 09.223.080S 80 09.223.085S 85 09.223.090S 90 Warning: Do not resterilize the Dynamic Locking Screw. Dynamic Locking Screw Instructions for Use Synthes 17 0x6.001.067_AB 15.11.12 07:01 Seite 18 Instruments for DLS 3.7 mm Dedicated instruments for DLS 3.7 mm 03.213.001 DLS Drill Sleeve 3.7, for Drill Bits ⭋ 3.1 mm 03.213.002 DLS Drill Bit ⭋ 3.1 mm with Stop, length 165 mm, 2-flute, for Quick Coupling Small fragment instruments 329.040 Bending Iron for Plates 2.4 to 3.5, length 145 mm (for use with 329.050) 329.050 Bending Iron for Plates 2.4 to 3.5, length 145 mm (for use with 329.040) 329.150 Bending Pliers for Plates 2.4 to 4.0, length 230 mm 329.290 Bending Pliers for Reconstruction Plates 2.7 and 3.5 319.010 Depth Gauge for Screws ⭋ 2.7 to 4.0 mm, measuring range up to 60 mm 511.770 Torque Limiter, 1.5 Nm, for Compact Air Drive and for Power Drive 511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling 18 Dynamic Locking Screw Synthes Instructions for Use 0x6.001.067_AB 15.11.12 07:01 Seite 19 314.116 Screwdriver Shaft Stardrive 3.5, T15, self-holding, for AO/ASIF Quick Coupling 397.705 Handle for Torque Limiter Nos. 511.770 and 511.771 311.431 Handle with Quick Coupling Dynamic Locking Screw Instructions for Use Synthes 19 0x6.001.067_AB 15.11.12 07:01 Seite 20 Instruments for DLS 5.0 mm Large fragment instruments 310.430 LCP Drill Bit ⭋ 4.3 mm with Stop, length 221 mm, 2-flute, for Quick Coupling 323.042 LCP Drill Sleeve 5.0, for Drill Bits ⭋ 4.3 mm 323.460 Universal Drill Guide 4.5/3.2, for neutral and load position 323.500 LCP Universal Drill Guide 4.5/5.0 314.119 Screwdriver Shaft Stardrive 4.5/5.0, T25, self-holding, for AO/ASIF Quick Coupling 314.164 Screwdriver Stardrive 4.5/5.0, T25, with Groove, length 240 mm 20 Dynamic Locking Screw Synthes Instructions for Use 0x6.001.067_AB 15.11.12 07:01 Seite Cvr3 314.163 Torque-limiting Screwdriver Stardrive, T25, self-holding, for Locking Screws ⭋ 5.0 mm 314.281 Holding Sleeve for Screws, for LCP 4.5/5.0 397.705 Handle for Torque Limiter Nos. 511.770 and 511.771 511.771 Torque Limiter, 4 Nm, for Compact Air Drive and Power Drive Dynamic Locking Screw Instructions for Use Synthes 21 All technique guides are available as PDF files at www.synthes.com/lit 0123 version AB Ö036.001.067öABNä 036.001.067 10/2012 30101298 © Synthes, Inc. or its affiliates Subject to modifications Synthes is a trademark of Synthes, Inc. or its affiliates 0x6.001.067_AB 15.11.12 07:01 Seite Cvr4