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Implants trauma Clavicle 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.

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications P. 8 Time of operation 2. Surgical Technique P. 10 Positioning of the patient P. 11 Access P. 11 Exposure P. 12 Reduction P. 13 Plate insertion P. 14 Placement of the screws P. 19 Postoperative treatment P. 19 Explantation P. 19 Summary 3. Information P. 21 Locking P. 21 Dotize® P. 22 Order list P. 24 Sterilization guidelines P. 26 Notes

Preface Locking Clavicle Plate System is a tried and tested osteosynthesis system for various clavicle fractures. The special feature of this implant is the free choice of screw placement. So the user is able to set every desired screw in every hole (either locking or non-locking screw). The free choice of screw angulation (+/- 15°, see page 21) provides an advantage in fracture treatment, especially in the case of complex fractures.

Screws Special advantages: • All three screw types can be used in each plate hole • Four different plate variants allow surgical treatment for numerous types of clavicle fractures • For taking over forces - direct contact between plate and bone is not necessary (principle of Fixateur Interne) 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=3.5mm, SH Spiral Drill, D=2.0mm, L=100mm, AO Connector...

Properties Properties of the material: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of implant after fracture has healed • Improved fatigue strength of implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Multi-directional locking • Anatomically plate design Clavicle Plate medial: Clavicle Plate lateral: • Turn 180° for right and left version • Plate lengths: 6, 8, 10-hole • Plate strenght: 2.5mm and 3.5mm • Version left/right • Plate length: 4-hole, Plate strength: 2.5mm • Plate length: 6-hole, Plate strength: 3.5mm Note:...

Indications, Contraindications & Time of operation Indications: • • • • All fractures of the clavicle in metaphyseal and diaphyseal areas Hygienisation of pseudoarthroses with or without spongiosa graft Corrective osteotomy Open and closed fractures Existing infections in the fracture zone and operation area Common situations that do not allow osteosynthesis Obesity Lack of patient compliance Time of operation: • Immediately after trauma or delayed • After regression of swelling

Surgical Technique

Positioning of the patient • Semi-sitting angle of about 30° - 40°, shoulder freely moveable (optional shoulder table) • The arm should be freely moveable to allow fracture reduction • General anaesthesia, regional anaesthesia or combined

Access Outline fracture and draw incision line on the skin. A horizontal dashed line marks the place for skin incision. Vertical marks show the position for a tension free suture. The incision should be made 1-2cm away from the fracture line to avoid placement of the suture directly over the plate. Exposure Supraclavicular approach: • Skin incision parallel to the clavicle in the supraclavicular fossa above the portion of the clavicle which is to be exposed Anterosuperior approach (sabre-cut incision) • Half-moon shaped incision over the middle of the clavicle with short dorsal branch

Reduction • Temporary fixation of the fracture parts using forceps • Seek compression of the fracture • Control under image converter Clavicle Plate medial Clavicle Plate lateral

Plate insertion Insert the plate from lateral to medial under the bone holding forceps and additionally fix in place with two clamps. Confirmation of correct plate position under image converter (optional).

Placement of the screws Use the drill guide, D=2.7/2.0mm (62202) to bore holes with the spiral drill D=2.7mm, L=100mm, AO Connector (61273-100) into the two plate holes close to fracture. Attention: To avoid disruption of soft tissue, nerves and/or blood vessels place a Hohmann retractor under the clavicle during drilling (or drill oscillating). Do not use locking screws close to fracture. Use the screwdriver, WS 2.5, self-holding sleeve (56252) to insert D=3.5mm cortical screws (32351-XX) of appropriate lengths determined previously with the depth gauge, solid small fragment screws...

Then drill holes into the adjacent plate holes using the drill guide, D=2.7/2.0mm (62202) to bore holes with the spiral drill D=2.7mm, L=100mm, AO Connector (61273-100). Attention: To avoid disruption of soft tissue, nerves and/or blood vessels place a Hohmann retractor under the clavicle during drilling (or drill oscillating). Do not use locking screws close to fracture. Use the screwdriver, WS 2.5, self-holding sleeve (56252) to insert D=3.5mm cortical screws (32351-XX) of appropriate lengths determined previously with the depth gauge, solid small fragment screws (59022).

Clavicle Plate medial Clavicle Plate lateral

Subsequently, place either D=3.5mm locking cortical or cancellous screws (37351-XXN/37352-XX-N) in plate holes far to fracture. Use the drill guide, D=2.7/2.0mm (62202) to bore holes with the spiral drill D=2.0mm or D=2.7mm, L=100mm, AO Connector (61203-100/61273-100) into plate holes far to fracture. Attention: To avoid disruption of soft tissue, nerves and/or blood vessels place a Hohmann retractor under the clavicle during drilling (or drill oscillating). Do not use locking screws close to fracture. Use the screwdriver, WS 2.5, self-holding sleeve (56252) to insert D=3.5mm locking...