Implants trauma Straight Locking Plates System

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, plate might break. All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent...

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Time of operation 2. Surgical Technique P. 8 Pre-operative patient preparation P. 8 Exposure P. 10 Straight Locking Plate 1.5mm P. 12 Straight Locking Plate 2.0mm P. 14 Straight Locking Plate 3.5/4.5mm P. 16 Postoperative treatment P. 16 Explantation P. 17 Notes 3. Information P. 17 Locking P. 17 Dotize® P. 18 Order list P. 22 Reconditioning Manual

Preface ITS. provides various Straight Locking Plates with different plate strengths and lengths covering a wide range of indications for shaft fractures. The special feature of these implants is the free choice of screw placement. The user is able to set any desired screw in any hole either locking or non-locking screw (except long hole). The free choice of screw angulation (+/- 15°, see page 17) provides an advantage in fracture treatment, especially in the case of complex fractures.

Screws Straight Locking Plate 1.5/2.0mm 37351-XX-N Cortical Screw, locking, D=3.5mm, SH Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Spiral Drill, D=2.7mm, L=100mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Cancellous Screw, locking, D=4.2mm, SH Spiral Drill, D=2.5mm, L=110mm, AO Connector Screwdriver, WS 2.5, self-holding sleeve Screws Straight Locking Plate 3.5/4.5mm 37455-XX Cortical Screw, locking, D=4.5mm Spiral Drill, D=3.2mm, L=145mm, AO Connector Screwdriver, WS 3.5, conic, self-holding Spiral Drill, D=3.2mm, L=145mm, AO Connector Screwdriver,...

Properties Properties of the material: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Straight Plate 3.5/4.5mm: Fracture gap compression up to 8mm

Time of operation • Immediately after trauma or delayed • After regression of swelling Pre-operative patient preparation • General anaesthesia, regional anaesthesia or combined can be used • Tourniquet/partial deprivation of the blood supply Exposure • Intra-operative x-ray fluoroscopy observation is required during the entire procedure • Incision to the limb subchondral bone fracture site • Transection of musculature if possible along the course of muscle fibers

Surgical Technique

Straight Locking Plate 1.5mm Indications: • The plate should primarily be used to reconstruct an anatomic situation • Corrective osteotomies Contraindications: • The plate is not intended for shaft fractures of large bones such as humerus, femur and tibia • Advanced osteoporosis • In case of skin and soft tissue problems • Existing infections • Obesity • Lack of patient compliance Plate insertion • Anatomical reduction of the fracture segments • Temporary fixation of the plate using guide wires • Subsequent control under fluoroscopy • Optionally, the plate can be stabilized using the ITS. Temporary...

Placement of the screws Use the drill guide, D=2.7/2.0mm (62202) to bore with the spiral drill, D=2.7mm, L=100mm, AO Connector (61273-100) into the plate holes closest to the fracture. Use the screwdriver, WS 2.5, self-holding sleeve (56252) to insert D=3.5mm cortical screws (32351XX) of appropriate lengths determined previously with the depth gauge, solid small fragment screws (59022). Attention: It is recommended that locking screws are not used close to the fracture. Subsequently, place either D=3.5mm cortical or locking cortical screws (32351-XX/37351-XX-N) in plate holes far to the fracture....

Straight Locking Plate 2.0mm Indications: • The plate should primarily be used to reconstruct an anatomic situation • Corrective osteotomies Contraindications: • The plate is not intended for shaft fractures of large bones such as humerus, femur and tibia • Advanced osteoporosis • In case of skin and soft tissue problems • Existing infections • Obesity • Lack of patient compliance Plate insertion • Anatomical reduction of the fracture segments • Temporary fixation of the plate using guide wires • Subsequent control under fluoroscopy • Optionally, the plate can be stabilized using the ITS. Temporary...

Placement of the screws Use the drill guide, D=2.7/2.0mm (62202) to bore with the spiral drill, D=2.7mm, L=100mm, AO Connector (61273-100) into the plate holes closest to the fracture. Use the screwdriver, WS 2.5, self-holding sleeve (56252) to insert D=3.5mm cortical screws (32351XX) of appropriate lengths determined previously with the depth gauge, solid small fragment screws (59022). Attention: It is recommended that locking screws are not used close to the fracture. Subsequently, place either D=3.5mm cortical or locking cortical screws (32351-XX/37351-XX-N) in plate holes far to the fracture....

Straight Locking Plate 3.5/4.5mm Indications: • All diaphyseal fractures, especially when compression for fracture treatment is needed • Corrective osteotomies Advanced osteoporosis In case of skin and soft tissue problems Existing infections Obesity Lack of patient compliance Plate insertion • Anatomical reduction of the fracture parts • Temporary fixation of the plate using forceps • Subsequent control under fluoroscopy