LSS Longitudinal Sternal Stabilization Technique Guide: Midline Closure Developed in conjunction with Dr. Jeko Madjarov and Carolinas Medical Center www.klsmartinnorthamerica.com Products shown may not be licensed or cleared in all markets. Availability is subject to change without notice.Licensed for US and CA. One LSS plate (24-039-30-72) must be placed on each sternal half to stabilize the sternum. The straight edge of the plate will be placed on the sternum medially. Explanation of icons Screw diameter 2.3 mm PEEK 2 Polyether Ether Ketone Packaging unit Sterile packaged Plates are not designed for transverse fracture fixation, rib-to-rib fixation or the spanning of continuity defects. /1 1 24-039-30-72 LSS plate 20.8 cm PEEK 2 2 LSS Technique Guide: indications and contraindications LSS Longitudinal Sternal Stabilization The LSS Plating System includes plates and screws that are intended to be used in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, when applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness of each plate ranges from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3 mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire. Indications for Use: The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension. Contraindications: 1. Active infection. 2. Fracture fixation. 3. Patients with sternal anomalies that prevent proper placement of the device, blood supply limitations, insufficient quantity or quality of bone, severe osteoporosis, bone tumors in implant region or latent infection. 4. Patients with mental, physical, neurological or other conditions who are unwilling or incapable of following postoperative care instructions. 5. Foreign body sensitivity: Where material sensitivity is suspected, testing is to be completed prior to implantation. 6. Patients that are still growing. 3 LSS Technique Guide: implantation Implantation Step 1: Expose Step 2: Plate length Dissect the soft tissue from the surface of the anterior sternum to allow for complete visualization of the bone. This step should also be performed in revision cases that require wire removal due to sternal nonunion or for re-operation. Check the plate length, cut if necessary. Place the plate on the anterior surface of the sternum to ensure proper length. If the plate is too long, use the Wire/Plate Cutter (22-523-22-07) to cut to the desired length. The recommended length should cover the entire vertical length of the sternal half from the manubrium to the xiphoid. The surgeon must check the sternal halves to ensure adequate bone quality and quantity for bone screw fixation. Wire / plate cutter 4 Step 3: Measure Step 4: Select Measure the depth of the sternum at the anticipated screw hole locations before bone reduction to ensure the selection of appropriate screws. Use the Sternal Caliper (24-006-01-07) to determine sternum thickness. Select one LSS plate. Place the plate vertically on one sternal half. The straight edge of the plate should be positioned toward the midline. The lateral edge of the plate should lie at the lateral edge of the sternum or more to the rib side to ensure proper wire placement. Screws should be no longer than necessary to engage the posterior cortex. The surgeon should use extreme care to ensure the screw does not extend past the posterior surface. Do not use a screw that is longer than the measured thickness of the sternum. For example: If the sternum is 13 mm thick, use a 13 mm screw. If the sternum is 12 mm thick, use an 11 mm screw. Once the plate is in the desired location, select the appropriate length 2.3 mm maxDrive Sternal screw based on the recorded measurements. Place the screw in the desired screw hole by using the maxDriver (KLS-SD-1000) or screwdriver handle (25-407-01-07) and blade (25-486-97-07). The plate should be fixed by placing the screws in order, moving superior to inferior. The plate should be adapted with digital pressure during fixation to ensure the best possible contour. x a 0 20 17 14 11 10 20 30 40 Caliper maxDriver Screwdriver handle Screwdriver blade 5 LSS Technique Guide: implantation Step 5: Secure Step 6: Reduce The screw should be inserted by turning in a clockwise direction. The screw will lock into the plate. Screw placement is complete once the screw is fully engaged and the screw head is one full turn below anterior surface of the plate. Once the plates are appropriately fixed to each hemisterna, place monofilament stainless steel wires circumferentially around the sternum and over the plates. Note: Avoid over-tightening the screw once it is completely engaged into the plate. Screws should be placed in all holes of the plate. If screws are placed with the maxDriver (KLS-SD-1000), the surgeon should use the screwdriver handle (25-407-01-07) and blade (25-486-97-07) after screw placement to ensure the screws are completely locked into the plate. Screws may require additional tightening. The surgeon should use a simple, interrupted cerclage wire closure technique to approximate the sternal halves in the traditional manner. Wires should be tightened by tactile feel in the same method as for a wire-only closure. The surgeon should choose the correct number and placement of wires to ensure a proper closure. A minimum of eight (8) stainless steel suture wires with a diameter of 0.9 mm is recommended in conjunction with the plate. Repeat these steps to place the remaining plate. Note: The LSS plate is intended only to support the underlying bone and help mitigate wire pull through. The use of the LSS plate is not intended to change the method of wire closure that the surgeon would typically choose based on the patients specific needs. Plates should not be placed over transverse fractures. Do not place screws with more than 3o of angulation. Wires should be placed over convex area only. Do not place over a screw hole. Prior to sternal approximation, the surgeon should visually and digitally check the posterior table of the sternum to ensure a screw has not penetrated the posterior cortex as described in Step 3. maxDriver 6 Screwdriver handle screwdriver blade Step 7: Emergent Re-entry Step 8: Long-term Removal (if necessary) If emergent reentry is necessary, the wire can be cut with most wire cutters found in the operating room or crash cart. Cut and remove the wires. Remove all screws. After re-entry, the sternum can be reapproximated using the method in Step 6. Remove plates and dispose. Do not reuse implants. Wire / plate cutter 7 LSS Technique Guide: s crews, twist drills, and screwdrivers overview LSS Screws, twist drills, and screwdrivers Ø 2.3 mm Drill-Free maxDrive Sternal Screws Locking Self-retaining Ø 1.9 mm Twist Drills Ø Length 5 7 mm 24-023-07-09 24-023-07-91 50 mm – 25-458-19-07 9 mm 24-023-09-09 24-023-09-91 70 mm 7 mm 25-460-07-07 11 mm 24-023-11-09 24-023-11-91 70 mm 9 mm 25-460-09-07 13 mm 24-023-13-09 24-023-13-91 70 mm – 25-460-19-07 15 mm 24-023-15-09 24-023-15-91 17 mm 24-023-17-09 24-023-17-91 Length Stop KLS-BP-001 Battery pack for KLS-SD-1000 8 Explanation of icons Screw diameter 2.3 mm Steel Titanium J-Notch maxDrive Packaging unit Sterile packaged Ø 2.0/2.3 mm Blades suitable for Screwdrivers and Blades 25-407-01-07 25-410-00-07 25-411-00-07* Ratchet Ratchet, flattened KLS-SD-1000 50-817-20-07 50-817-20-07 25-486-97-07 25-486-98-07 X 25-486-97-07 X X X 25-486-98-07 X X X *For storage in Level One modules 9 LSS Technique Guide: instrumentation LSS Instrumentation 0 10 20 30 40 ½ ½ 50-501-40-07 Depth gauge 12-188-17-07 Cushing forceps 24-006-01-07 Caliper 17 cm, 6 1/2” serrated 17 cm, 6 3/4” 20 17 14 11 10 ½ Explanation of icons Steel Packaging unit Tungsten Carbide inserts ½ ½ 22-523-22-07 Wire / plate cutter 50-205-16-07 Plate holding forceps 22 cm, 8 3/4” 11 KLS Martin Group KLS Martin Australia Pty Ltd. Sydney · Australia Tel. +61 2 9439 5316 australia@klsmartin.com KLS Martin do Brasil Ltda. São Paulo · Brazil Tel. +55 11 3554 2299 brazil@klsmartin.com KLS Martin Medical (Shanghai) International Trading Co. Ltd. Shanghai · China Tel. +86 21 5820 6251 china@klsmartin.com Gebrüder Martin GmbH & Co. KG Tuttlingen · Germany Tel. +49 7461 706-0 info@klsmartin.com KLS Martin India Pvt Ltd. Chennai · India Tel. +91 44 66 442 300 india@klsmartin.com Martin Italia S.r.l. Milan · Italy Tel. +39 039 605 67 31 italia@klsmartin.com Nippon Martin K.K. Tokyo · Japan Tel. +81 3 3814 1431 nippon@klsmartin.com KLS Martin SE Asia Sdn. Bhd. Penang · Malaysia Tel. +604 505 7838 malaysia@klsmartin.com KLS Martin de México S.A. de C.V. Mexico City · Mexico mexico@klsmartin.com Martin Nederland/Marned B.V. Huizen · The Netherlands Tel. +31 35 523 45 38 nederland@klsmartin.com Gebrüder Martin GmbH & Co. KG Moscow · Russia Tel. +7 499 792-76-19 russia@klsmartin.com KLS Martin Taiwan Ltd. Taipei · Taiwan Tel. +886 2 2325 3169 taiwan@klsmartin.com Gebrüder Martin GmbH & Co. KG Dubai · United Arab Emirates Tel. +971 4 454 16 55 middleeast@klsmartin.com KLS Martin UK Ltd. London · United Kingdom Tel. +44 1189 000 570 uk@klsmartin.com KLS-Martin L.P. Mail: P.O. Box 16369 Jacksonville, FL 32245-6369 Office: 11201 Saint Johns Industrial Pkwy S. Jacksonville, FL 32246-7652 Tel. 904.641.7746 · 800.625.1557 Fax 904.641.7378 usa@klsmartin.com · www.klsmartinnorthamerica.com 91-600-04-57 · Rev 3 · 2021-08-26 · LSS Technique Guide · The information presented is intended to demonstrate a KLS-Martin L.P. product. Please refer to the IFU for the full list of indications, contraindications, warnings, precautions, and sterilization information. Always refer to the IFU before using any KLS-Martin L.P. product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients.