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CLS

CLS
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CLS

Product catalog summary
Preface: The Clavicle Locking Plate System is engineered for the osteosynthesis of clavicle fractures, providing flexibility in screw placement and angulation, which is advantageous for complex fractures. It includes various plate and screw types to suit different fracture scenarios.
Specifications: The system's plates are made from titanium, and the screws are composed of TiAl6V4 ELI. It features multidirectional locking and an anatomical design, with plates available in various lengths and strengths for both medial and lateral clavicle applications.
Indications & Contraindications: This system is suitable for clavicle fractures in metaphyseal and diaphyseal areas, pseudoarthroses, corrective osteotomy, and both open and closed fractures. Contraindications include infections in the fracture zone and lack of patient compliance.
Surgical Procedure: The patient is positioned semi-sitting with a freely moveable shoulder. The procedure involves incision, exposure, reduction, plate insertion, and screw placement. Postoperative care includes shoulder-arm dressing and physiotherapy, with full exertion possible after 5-7 weeks.
Postoperative Treatment & Explantation: Implants can be removed after bone healing, typically one and a half years post-operation. The design minimizes issues like cold welding.
Locking Mechanism: Locking is achieved by the screw material being slightly harder than the plate, allowing the screw head to form a thread into the plate without pre-threading.
Sterilization Guidelines: Non-sterile implants and reusable instruments must be sterilized before use. Steam sterilization is recommended, with care to avoid damage during cleaning.
Order List: Includes various plate and screw sizes, along with necessary surgical tools like screwdrivers and drills.
Cleaning and Disinfection Procedures: Ensure all parts are accessible for cleaning, following manufacturer's instructions for cleaning agents. Rinse with clean water, use authorized disinfectants, and perform a final rinse at 90°C for thermal disinfection.
Drying: Drying should not exceed 110°C during the cleaning/disinfection cycle.
Inspection and Maintenance: Inspect each instrument to ensure cleanliness, lubricate movable mechanisms, and check the mobility and reassembly of disassembled instruments.
Sterilization: Hospitals are responsible for assembly, inspection, and packaging of instruments. Use heat/steam sterilization, following manufacturer's recommendations, and do not exceed maximum load for sterilization appliances.
Disposal: Follow hospital guidelines for disposal.
Patient Information: Inform patients about post-implantation behavior and the importance of reporting any negative changes or accidents.
Responsibility of the Hospital: Ensure proper care and maintenance of instruments to extend their service life. Dispose of worn or improperly functioning instruments. Returned products must be cleaned, disinfected, inspected, and sterilized, with a decontamination confirmation.
Important Note: Instructions are validated for re-use suitability. Reconditioners must ensure the preparation process achieves desired results through validation and routine inspections. Contact I.T.S. GmbH for questions or problems.
Symbols and Notes: Includes symbols for compliance with standards such as RL 93/42/EWG, ÖNORM EN ISO 13485, and ISO 17664, along with details on single use, expiry date, sterilization methods, order number, material, package content, and size.
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Catalog excerpts

CLS-1

Cl av icl e Cl av icl e Cl av icl e Cl av icl e CLS Pla te M edia l 2.5 mm Pla te M edia l 3.5 mm Pla te L ater al 2. 5mm Pla te L ater al 3. 5mm CLAVICLE LOCKING PLATES SYSTEM emergency team for broken bones®

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CLS-2

CONTENTS Preface 3 Screws 4 Properties 5 Indications & Contraindications 6 Time of operation 6 Positioning of the patient 7 Access 8 Exposure 8 Reduction Surgical Technique Preface 9 Plate insertion Placement of the screws 11 Postoperative Treatment 16 Explantation 16 Summary Information 10 16 Locking 17 Dotize® 17 Order list 18 Sterilization guidelines 20 Notes 22

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CLS-3

Preface 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 17) provides an advantage in fracture treatment, especially in the case of complex fractures. 03

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CLS-4

Clavicle Locking Plates System 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) 37351-xx-N Cortical Screw, locking, D=3.5mm, SH 31773-ÌOO Spiral Drill, D=2.7mm, L=100mm, AO Connector Self-holding sleeve 31273 100 Spiral Drill, D=2.7mm, L=100mm, AO Connector self-holding sleeve 37352-xx-N Cancellous Screw, locking, D=3.5tnm, SH 31203-100 Spiral Drill, D=2.0mm,...

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CLS-5

Properties Properties of the material: Properties of the implant: • • • • • • • Multidirectional locking • Anatomically plate design 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 Clavicle Plate: Clavicle Plate Lateral: • Turn 180° for right and left version • Plate lengths: 6, 8, 10-hole • Plate strength: 2.5mm and 3.5mm • Version left/right • Plate length: 4-hole, Plate strength: 2.5mm • Plate length: 6-hole, Plate strength:...

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CLS-6

Indications, Contraindications & Time of operatioi • 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 ■ Lack of patient compliance • Immediately after trauma or delayed

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CLS-7

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 07

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CLS-8

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 08

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CLS-9

Reduction • Temporary fixation of the fracture parts using forceps • Seek compression of the fracture • Control under image converter Medial Clavicle Plate Lateral Clavicle Plate 09

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CLS-10

Plate insertion Insert the plate from lateral to medial under the bone holding forceps and additionally fix in place two clamps. Confirmation of correct plate position under image converter (optional). 10

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CLS-11

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 (59022)....

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CLS-12

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).

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CLS-13

Medial Clavicle Plate Lateral Clavicle Plate 13

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CLS-14

Subsequently, place either D=3.5mm locking cortical or cancellous screws (37351-XX-N/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 cortical...

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CLS-15

Finally, control plate position under image converter. Medial Clavicle Plate Lateral Clavicle Plate 15

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.