SMV Scientific Bone Plate and Screw System Surgical Technique

Transcription

1 SMV Scientific Bone Plate and Screw System Surgical Technique Description: The SMV Scientific Bone Plate and Screw System consists of non-locking plates and bone screw fasteners in a variety of lengths, diameters, and widths to accommodate different anatomic sizes of patients. The devices are provided sterile and non-sterile. All devices are manufactured from Stainless Steel per ASTM F138 General System Information: The surgeon must select the type and size of the implant that best meets the patient s surgical needs. Refer to the Instructions for Use (package insert) for indications, contraindications, precautions, warnings and cleaning instructions. To obtain these materials or to obtain more information about products, please contact Customer Service. Indications for Use: The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including periarticular and intraarticular fractures. Table of Contents Preparation and Reduction Preparation Plate Selection Contouring... 2 Plate Placement... 2 Screw Insertion Neutral insertion of a bone screw fastener Dynamic Compression using a bone screw fastener... 3 Removal... 4 Implants... 5 Instruments... 8 Manufactured By SMV Scientific 5113 Southwest Pkwy, Ste 150 Austin, TX 78735

2 Implant Overview The SMV Scientific Bone Plate and Screw System consists of non-locking plates and bone screw fasteners in a variety of lengths, diameters, and widths to accommodate different anatomic sizes of patients. The devices are provided sterile and non-sterile. All devices are manufactured from Stainless Steel per ASTM F138 The goal of any surgical intervention in fracture treatment is to restore anatomical structure and stabilize the fracture to allow a return to normal function. The SMV Bone Plate and Screw system utilizes conventional compression plates and bone screws to perform internal fixation of fractures, osteotomies, and non-unions to restore the patient to full normal function. All of the plates included in the SMV Bone Plate and Screw system are non-locking and have a series of holes and slots in which are designed to be utilized in conventional compression plating techniques. Surgical Technique Preparation and Reduction 1. Preparation Dissect down to the bone and reduce the fracture utilizing standard orthopedic instruments and techniques. Anatomical reduction techniques should be used to position the fractured bone segments for fixation. 2. Plate Selection Following fracture reduction select the SMV Bone plate that best accommodates patient anatomy and fracture pattern. SMV Bone plates are offered in various lengths, widths, and pre-contoured shapes. The proper length and configuration should be selected based on clinical principles and expertise and in compliance with the indications for use, contraindications, and warnings found in the SMV device labeling; including the information for use. 3. Contouring The SMV Bone plates may be contoured to better approximate the patient anatomy. 4. Lag Screw Insertion Prior to placing the plate for internal fixation lag screws may be used to hold length and alignment and obtain compression across the fracture site. Depending on the complexity and severity of the fracture, lag screw fixation may sufficiently stabilize the fragments for proper healing and no subsequent plate technique is required. Lag screws should be implanted utilizing standard orthopedic instruments and lag screw techniques and as described in the SMV Bone Screws surgical technique guide. Plate Placement Place the plate on the appropriate location of the fractured bone segment. The middle of the plate should be positioned over the fracture site if compression of fracture segments is desired utilizing the compression slots

3 in the plate. Care should be taken to ensure that an appropriate length of plate is utilized allowing for sufficient screw insertion on both sides of the fracture. The plates may be held temporarily in place with standard holding instrumentation. Further reduction can be accommodated through the plate during screw insertion. Screw Insertion 1. Neutral insertion of a bone screw fastener When placing a bone screw fastener in a neutral position the drill should be located in the center of the compression slot prior to perforating the near cortex. Once the proper location has been found drill the near and far cortices of the bone with the appropriately sized drill bit. The drill bit diameter is determined by the core diameter of the screw. Insert a depth gauge into the hole which was drilled. Use the depth gauge to measure the length of the hole which was drilled to determine the desired length of the screw that will be inserted. When utilizing screws that do not have the self-tapping cutting flutes use the appropriately sized tap to prepare the bone for screw insertion. When using the self-tapping screws, tapping is not required in most instances. Identify the screwdriver in the orthopedic set. Attach the appropriately sized screw to the correct screw driver. Advance the screw by turning the screwdriver clockwise until the screw is firmly seated in the bone. Do not use excessive force as the screw threads may strip eliminating fixation in the bone. 2. Dynamic Compression using a bone screw fastener When using a bone screw fastener to apply axial compression to the fracture the drill should be located eccentrically in the compression slot on the side of the slot farthest from the fracture prior to perforating the near cortex. Once the proper location has been found drill the near and far cortices of the bone with the appropriately sized drill bit. The drill bit diameter is determined by the core diameter of the screw. Insert a depth gauge into the hole which was drilled. Use the depth gauge to measure the length of the hole which was drilled to determine the desired length of the screw that will be inserted. When utilizing screws that do not have the self-tapping cutting flutes use the appropriately sized tap to prepare the bone for screw insertion. When using the self-tapping screws, tapping is not required in most instances. Identify the screwdriver in the orthopedic set. Attach the appropriately sized screw to the correct screw driver. Advance the screw by turning the screwdriver clockwise until the screw is firmly seated in the bone. Do not use excessive force as the screw threads may strip eliminating fixation in the bone. Tightening of the bone screw fastener will result in dynamic compression of the fracture as the screw head travels along the compression feature in the slots.

4 Removal To remove the SMV Bone plate and screw, utilize the correct screwdriver and turn the screw in a counter-clockwise direction until the screw is completely removed from the plate. Once all of the screws have been removed from the bone the plate can also be removed from the bone and disposed of according to the device labeling.

5 Implants All implant components are manufactured from Stainless steel per ASTM F138. Screws The SMV Scientific Bone Plate and Screw System includes the following screws: Ø4.5mm Cortex Screws o 14 70mm lengths in 1mm o mm lengths in 5mm Ø4.0mm Cortex Screws o 14 70mm lengths in 1mm o mm lengths in 5mm Ø3.5mm Cortex Screws o 14 70mm lengths in 1mm o mm lengths in 5mm Ø3.0mm Cortex Screws o 14 70mm lengths in 1mm o mm lengths in 5mm Ø2.7mm Cortex Screws o 6 76mm lengths in 1mm Ø2.4mm Cortex Screws o 6 76mm lengths in 1mm Ø2.0mm Cortex Screws o 6 76mm lengths in 1mm SMV Scientific, 5113 Southwest Pkwy, Ste 150, Austin, Texas, USA Page 5 of 8

6 Plates The SMV Scientific Bone Plate and Screw System includes the following plates: Plate Description Size Range Hole Range 1/3rd Tubular Plates w/out collar 21mm-117mm 2 to 10 Straight Compression Plates 33mm-293mm 2 to 16 1/3rd Tubular Plates w collar 21mm-117mm 3 to 12 Straight Reconstruction Plate 46mm-262mm 4 to (2.4)/3.5mm Lateral Distal Fibula Plate 73mm-177mm 3 to (2.4)/3.5mm Posterolateral Distal Fibula Plate T Compression Plates, 3 hole head, right angle 73mm-177mm 3 to mm-97mm 3 to 8 T Compression Plates, 4 hole head, right angle 50mm-100mm 3 to 8 T Compression Plates, 3 hole head, oblique right 52mm-107mm 3 to 8 SMV Scientific, 5113 Southwest Pkwy, Ste 150, Austin, Texas, USA Page 6 of 8

7 T Compression Plates, 3 hole head, oblique left 52mm-107mm 3 to 8 3.5mm Curved Reconstruction Plates 46mm-214mm 4 to mm Broad Compression Plate 90mm-259mm 7 to mm Quarter Tubular Plate w/ collar 33mm-117mm 3 to mm Narrow Compression Plate 70mm-214mm 4 to mm Broad Compression Plate 106mm-250mm 6 to mm T Compression Plate, 2 hole head, right angle 84mm-148mm 4 to 8 4.5mm T Buttress Plate 80mm 4 to 5 4.5mm L Buttress Plate 80-95mm 4 to 5 4.5mm L Buttress Plate, Offset Left 80-95mm 4 to 5 4.5mm Semi-Tubular Plate 71mm-119mm 4 to 7 SMV Scientific, 5113 Southwest Pkwy, Ste 150, Austin, Texas, USA Page 7 of 8

8 Instruments Part Description Material Class 1.5mm Drill, 85mm L Stainless Steel I 2.0mm Drill, 100mm L Stainless Steel I 2.5mm Drill, 110mm L Stainless Steel I 2.7mm Drill, 100mm L Stainless Steel I 3.2mm Drill, 145mm L Stainless Steel I 3.5mm Drill, 110mm L Stainless Steel I 4.5mm Drill, 145mm L Stainless Steel I 3.5mm Hex Driver, 100mm L Stainless Steel I 2.5mm Hex Driver, 100mm L Stainless Steel I 1.5mm Hex Driver, 100mm L Stainless Steel I T6 Hexalobe Driver, 100mm L Stainless Steel I T8 Hexalobe Driver, 100mm L Stainless Steel I T15 Hexalobe Driver, 100mm L Stainless Steel I T25 Hexalobe Driver, 100mm L Stainless Steel I Depth Gauge Stainless Steel I Depth Gauge - Small Frag Stainless Steel I Depth Gauge - Large Frag Stainless Steel I AO Quick Connect Handle Stainless Steel I AO QC Handle, Inline, Non-ratcheting Stainless Steel I 2.0mm Bone Screw Tap, 95mm Stainless Steel I 2.4mm Bone Screw Tap, 95mm Stainless Steel I 2.7mm Bone Screw Tap, 95mm Stainless Steel I 3.0mm Bone Screw Tap, 95mm Stainless Steel I 3.5mm Bone Screw Tap, 95mm Stainless Steel I 4.0mm Bone Screw Tap, 95mm Stainless Steel I 4.5mm Bone Screw Tap, 95mm Stainless Steel I Reduction Bone Forcep Stainless Steel I Tenac Stainless Steel I Torque Limiting Attachment Stainless Steel I Sharp Hook Stainless Steel I Countersink Stainless Steel I Bending Templates Aluminum I Plate Holding Forceps Stainless Steel I Hohmann Retractor Stainless Steel I Periosteal Elevator Stainless Steel I Drill Guide Stainless Steel I SMV Scientific, 5113 Southwest Pkwy, Ste 150, Austin, Texas, USA Page 8 of 8