Implants trauma Tubular 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 Pre-operative planning P. 8 Indications P. 9 Contraindications P. 9 Time of operation 2. Surgical technique P. 10 Pre-operative patient preparation P. 10 Reduction P. 11 Placement of the screws P. 12 Postoperative treatment P. 12 Explantation 3. Information P. 13 Locking P. 13 Dotize® P. 14 Order list P. 16 Reconditioning Manual P. 18 Notes

Preface The Tubular Locking Plates System is an osteosynthesis system for various diaphyseal and metaphyseal fractures. The special feature of this implant 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. The free choice of screw angulation (+/- 15°, see page 13) provides an advantage in fracture treatment, especially in the case of complex fractures.

Spiral Drill, D=2.0mm, L=100mm, AO Connector Cancellous Stabilization Screw, D=3.0mm, RH Spiral Drill, D=2.0mm, L=100mm, AO Connector Cortical Stabilization Screw, D=3.0mm, RH Spiral Drill, D=2.4mm, L=100mm, AO Connector Screwdriver, Torque, T9x70 OPTIONAL (ON REQUEST) Spiral Drill, D=1.8mm, L=100mm, AO Connector Screwdriver, Torque, T9x70 OPTIONAL (ON REQUEST) Guide Wire, Steel, D=1.6mm, L=150mm, TR, with thread

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 • Multi-directional Locking • Anatomically shaped • 2 plate versions: diaphyseal and distal (multiple points of fixation in the distal area) • Free choice of plate position (lateral, dorsal, ventral) • Plate lengths, universal: 5, 6, 7, 8, 10-hole • Plate strength, universal: 2.0mm • Plate lengths, distal: 3, 4, 5, 6,...

Pre-operative planning Indications • For treatment of fractures, osteotomies and degenerative transformations. Primary: fibula; secondary: radius, ulna • Pediatric humeral and tibia fractures

Contraindications • The plates are not intended for shaft fractures of large bones such as humerus, femur and tibia (except pediatric humeral and tibia fractures) • Common situations that do not allow osteosynthesis • With advanced osteoporosis • In cases of skin and soft tissue problems that prevent a tension-free skin closure • Obesity • Lack of patient compliance Time of operation • Immediately after trauma or delayed • After regression of swelling

Pre-operative patient preparation • General anaesthesia, regional anaesthesia or combination can be used • Tourniquet/partial deprivation of the blood supply Reduction • Temporary fixation of the plate using guide wires • Anatomical reduction of the fracture segments to the plate • Subsequent control under fluoroscopy Optionally, the plate can be stabilized using the ITS. Temporary Plate Holder (58164-15

Placement of the screws Use the drill guide, D=2.0/2.4mm (62215) to bore with the spiral drill, D=2.0mm, L=100mm, AO Connector (61203-100) into the plate holes close to fracture. Determine appropriate length using the depth gauge, PROlock II (59026). Insert the D=2.7mm cortical screws (32271-XX) with the screwdriver, torque, T9x70, (56095-70). Subsequently, place either locking or non-locking screws in the plate holes far to the fracture. (suitable drills and screws see page 6). Finally, control plate position under fluoroscopy.

Postoperative Information treatment • Physical therapy immediately following surgery (no immobilization required) • In case of poor bone quality or insecure fixation, movement fixator for a maximum of 6 weeks • When a locking screw connection has been used, it is necessary to be aware that the diagnosis of a non-union may be very delayed. Explantation If desired by the patient, the implant can be removed Removal should be performed at the earliest 6 months - 1 1/2 years later or after radiographic verification of the healed bone. The problem of cold welding was resolved by using a special surface...

Locking Locking works because: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Type III anodization Dotize Type II anodization + Film becomes an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration Type - III - No visible cosmetic effect Dotize® Type - II Ti-Oxid Anodization Type II leads...

Order list Universal Tubular Plate, 5-Hole 21601-5 Universal Tubular Plate, 6-Hole 21601-6 Universal Tubular Plate, 7-Hole 21601-7 Universal Tubular Plate, 8-Hole 21601-8 Universal Tubular Plate, 10-Hole 21601-10 Distal Tubular Plate, 3-Hole, Left 21602-3 Distal Tubular Plate, 3-Hole, Right 21603-3 Distal Tubular Plate, 4-Hole, Left 21602-4 Distal Tubular Plate, 4-Hole, Right 21603-4 Distal Tubular Plate, 5-Hole, Left 21602-5 Distal Tubular Plate, 5-Hole, Right 21603-5 Distal Tubular Plate, 6-Hole, Left 21602-6 Distal Tubular Plate, 6-Hole, Right 21603-6 Distal Tubular Plate, 7-Hole, Left 21602-7...