1 Delivery. 4 Control. 3 Unpacking. 2 Storage. 6 Cleaning. 8 Control. 9 Packaging of the kit. 11 Surgery. 16 Traceability. 18 Packaging of the kit

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Lionel Bishop
5 years ago
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1 Clavicle

With a non sterile standard kit Calling on medical staff Constraints Complex traceability Contracted out sterilization Suppliers deadline High costs Complex process Stocks Control

Sterilization Surgery Decontamination 3 Cleaning 4 Drying 5 Control 6 Traceability Bulky storage Incomplete Kit incomplet kit 7 Restocking 8 Packaging of the kit 9 Sterilization 0

2 With a non sterile standard kit Calling on medical staff Constraints Complex traceability Contracted out sterilization Suppliers deadline High costs Complex process Stocks Control Cleaning Decontamination HOSPITAL Delivery 5 Decontamination Storage 6 Cleaning 3 Unpacking 7 Drying 4 Control 8 Control Sterilization Surgeon 9 Packaging of the kit 0 Sterilization Surgery Decontamination 3 Cleaning 4 Drying 5 Control 6 Traceability Bulky storage Incomplete Kit incomplet kit 7 Restocking 8 Packaging of the kit 9 Sterilization 0 Storage Prevents an effective solution & a quick response Defective sterilization Incomplete kit Damaged instrumentation INCREASED RISKS NON OPTIMIZED surgery URGENT SURGICAL CASES COMPROMISED

3 With the Safety TRACEABILITY Risk of contamination kit Cost efficiency Efficiency Controlled stocks Simplified control Delivery Storage 3 Surgery Cleaning Decontamination Sterilization Surgeon An effective solution & a quick response Sundry expenses Optimized storage Hospital Available when needed READY-TO-USE FOR SURGERY Optimized handling of URGENT SURGICAL CASES with state-of-the-art implants

Safety: The Initial C kit is fully traceable and has a shelf life of 5 years. Its instrumentation and implants are always new and have never been opened or used before.

4 Safety: The Initial C kit is fully traceable and has a shelf life of 5 years. Its instrumentation and implants are always new and have never been opened or used before. Available when needed: The Initial C kit comes pre-sterilized and ready to use. The combination of sterile implants and single use instrumentation in a single packaging makes Initial C ideal for use in urgent surgical cases. innovation Storage: Initial C kit can be easily stored in the operating room because of its small size. Costs: Initial C is a cost-effective solution. The additional costs including cleaning, decontamination, sterilization of kits are cancelled. Contamination: The combination of sterile implants and sterile single-use instrumentation minimizes contamination risks. Buying procedure: Initial C facilitates buying procedures: restocking and orders are simplified, stock management is optimized.

$are dedicated to the fixation of fractures, mal-unions, non-unions, and$ osteotomies of the clavicle in adults.

Acute or chronic, local or systemic infections.

Muscular deficit, neurological deficiency or behavioural disorders which could

Allergy to one of the materials used or sensitivity to foreign bodies.

follow post-operative care recommendations.

A comprehensive range of plates Precontoured implant Plates dedicated to the

Optimized anatomical congruence > Bendable midshaft plate, size and size The

$treatment of middle-third clavicle fractures, positioned at the level of the$ Plates dedicated to the lateral part of clavicle > Lateral plate, size and size >

Plates dedicated to the lateral part of clavicle > Lateral plate, size and size >

proprietary state-ofthe-art mapping technology to establish an optimized

5 Initial C kits Technical features Indications The implants of the Initial C range are dedicated to the fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle in adults. Contraindications Serious vascular deterioration, bone devitalization. Pregnancy. Acute or chronic, local or systemic infections. Lack of musculo-cutaneous cover, severe vascular deficiency affecting the concerned area. Insufficient bone quality preventing a good fixation of the implant into the bone. Muscular deficit, neurological deficiency or behavioural disorders which could submit the osteosynthesis to abnormal mechanical strains. Allergy to one of the materials used or sensitivity to foreign bodies. Serious problems of non-compliance, mental or neurological disorders, failure to follow post-operative care recommendations. Unstable physical and/or mental condition. A comprehensive range of plates Precontoured implant Plates dedicated to the midshaft part of the clavicle > Midshaft plate, size Midshaft lateral plate Optimized anatomical congruence > Bendable midshaft plate, size and size The midshaft lateral plate (size and size ) is an additional solution for the treatment of middle-third clavicle fractures, positioned at the level of the coracoclaviclar ligament. Plates dedicated to the lateral part of clavicle > Lateral plate, size and size > Lateral bendable plate, size The design of the implants is the result of a proprietary state-ofthe-art mapping technology to establish an optimized congruence between the plate and the bone. BENDABLE PLATES Bendable plates offer bendable areas which allow an optimized adjusting of the plate with the bending pliers. They are available separately, on demand, in non sterile version. Bending is only possible in the areas intended for this purpose. A bendable area must be bent only once, in one direction and not be performed excessively. The holes must be protected so as to avoid damaging of the fixation.

Initial C kits Technical features Fixations

kits Surgical technique Example: surgical

(CMLD) The threads under the screw head and

facilitate the positioning of the plate: Ø3.

5LxxD), FEATURES - The screw head is stopped

screw head is buried in the plate, - Plate

which offers one type of hole for two types

locking fixation The DTS3 technology ensures

6 Initial C kits Technical features Fixations and screws Polyaxial holes: Ø.8 mm locking screws (SDT.8LxxD), Monoaxial locking system Initial C kits Surgical technique Example: surgical technique with a midshaft lateral plate (CMLD) The threads under the screw head and inside the hole have strictly the same characteristics. Handle for guide gauge Oblong hole to facilitate the positioning of the plate: Ø3.5 mm cortical screw (CT3.5LxxD), FEATURES - The screw head is stopped in the hole, ensuring its locking, - The screw head is buried in the plate, - Plate and screws are all made of titanium alloy. Before performing the drilling into the oblong hole, snap the handle for guide gauge on the desired guide gauge. Monoaxial holes: A versatile fixation system which offers one type of hole for two types of screws: > Ø3.5 mm cortical screw (CT3.5xxD), > Ø3.5 mm locking screw (SOT3.5LxxD), Angular range: +/- 0 polyaxial locking fixation The DTS3 technology ensures the locking of the screw into the plate while allowing their angulation. The DTS3 polyaxial locking holes are located in the epiphyseal area. This system helps for the insertion of the screws in diverging or converging directions and strengthens the assembly. Handle for guide gauge Guide gauge Hexalobe screw recess design. Angulation +/ rotation Dualtec System III Technology Polyaxial locking fixation

7 Initial C kits Surgical technique Option Option. Using the midshaft and midshaft lateral templates (ANC838), define the suitable plate, then determine the appropriate kit.. Position the plate using the LAT and MED marks. 3. Snap the handle for guide gauge and perform the drilling using Ø.7 mm threaded guide gauge into the lateral oblong hole. Option : Determine the screw length using the gauge. Option : Determine the screw length using the length gauge. Option Option Final result 4. Then insert the Ø3.5 mm light blue cortical screw using the T5 screwdriver. Repeat the same procedure for the medial oblong hole. 5. Using the Ø.7 mm threaded guide gauge, drill (Ø.7 mm). Option : Determine the screw length using the gauge. Option : Determine the screw length using the length gauge. 6. Insert the Ø3.5 mm blue locking screw using the T5 screwdriver. Repeat previous steps to insert the remaining Ø3.5 mm locking screws in the plate.

7 mm threaded guide gauge (blue) into the

Option : Determine the screw length using

oblong hole. Option Option Final result 4.

0 mm threaded guide gauge (grey), choose the

8 mm non anodized screws in the polyaxial

0 mm) and measure the screws length directly

Using the T8 screwdriver (grey), insert and

7 mm threaded guide gauge (blue), drill (Ø.

8 Initial C kits Surgical technique Option Example: surgical technique with a lateral plate (CLD) Option. Using the lateral templates (ANC839), define the suitable plate, then determine the appropriate kit.. Snap the handle for guide gauge and perform the drilling using the Ø.7 mm threaded guide gauge (blue) into the lateral oblong hole. Option : Determine the screw length using the gauge. Option : Determine the screw length using the length gauge. 3. Insert the Ø3.5 mm light blue cortical screw using the T5 screwdriver (blue). Repeat the same procedure for the medial oblong hole. Option Option Final result 4. Using the Ø.0 mm threaded guide gauge (grey), choose the angle of the Ø.8 mm non anodized screws in the polyaxial holes then drill (Ø.0 mm) and measure the screws length directly on the gauge or with the length gauge. Using the T8 screwdriver (grey), insert and lock the Ø.8 mm non anodized screws. 5. Using the Ø.7 mm threaded guide gauge (blue), drill (Ø.7 mm). Option : Determine the screw length using the gauge. Option : Determine the screw length using the length gauge. Insert a Ø3.5 mm blue locking screw using the T5 screwdriver (blue). Repeat previous steps to insert the remaining Ø3.5 mm locking screws in the plate.

Initial C kits - References Midshaft and midshaft lateral clavicle kits content INITIAL C KITS - MIDSHAFT PLATES AND MIDSHAFT LATERAL PLATES INITIAL C KITS CONTENT - IMPLANTS QUANTITY PER KIT Ref.

9 Initial C kits - References Midshaft and midshaft lateral clavicle kits content INITIAL C KITS - MIDSHAFT PLATES AND MIDSHAFT LATERAL PLATES INITIAL C KITS CONTENT - IMPLANTS QUANTITY PER KIT Ref. CMD CMG CMLD CMLG CMLD CMLG Description Clavicle kit - Midshaft part - Size - Right Clavicle kit - Midshaft part - Size - Left Clavicle kit - Lateral midshaft part - Size - Right Clavicle kit - Lateral midshaft part - Size - Left Clavicle kit - Lateral midshaft part - Size - Right Clavicle kit - Lateral midshaft part - Size - Left PLATES Ref. CTDMD or CTGMD CTDMLD or CTGMLD CTDMLD or CTGMLD Description CMD/G CMLD/G CMLD/G CBMD/G CBMD/G Clavicle plate - Midshaft part - Size - Right or Left Clavicle plate - Lateral midshaft part - Size - Right or Left Clavicle plate - Lateral midshaft part - Size - Right or Left INITIAL C KITS - BENDABLE PLATES CBTDMD or CBTGMD Bendable clavicle plate - Midshaft part Size - Right or Left Ref. CBMD CBMG CBMD CBMG Description Clavicle kit - Bendable - Midshaft part - Size - Right Clavicle kit - Bendable - Midshaft part - Size - Left Clavicle kit - Bendable - Midshaft part - Size - Right Clavicle kit - Bendable - Midshaft part - Size - Left STANDARD CORTICAL SCREWS Ø3.5 MM CBTDMD or CBTGMD Bendable clavicle plate - Midshaft part Size - Right or Left CT3.5LD Standard cortical screw - Ø3.5 mm - L mm - - CT3.5L4D Standard cortical screw - Ø3.5 mm - L 4 mm CT3.5L6D Standard cortical screw - Ø3.5 mm - L 6 mm CT3.5L8D Standard cortical screw - Ø3.5 mm - L 8 mm - - INITIAL C KITS CONTENT - INSTRUMENTS Description CMxD/G CMLxD/G CBMxD/G T5 prehensor screwdriver Ø.7 mm threaded guide gauge for Ø3.5 mm screws Ø.7 mm quick coupling drill bit - L 0 mm Handle for guide gauge Length gauge for Ø.8 and Ø3.5 mm screws Pin Ø. L0 mm LOCKING SCREWS Ø3.5 MM SOT3.5LD Locking screw - Ø3.5 mm - L mm SOT3.5L4D Locking screw - Ø3.5 mm - L 4 mm SOT3.5L6D Locking screw - Ø3.5 mm - L 6 mm SOT3.5L8D Locking screw - Ø3.5 mm - L 8 mm -

10 Initial C kits - References Lateral clavicle kits content INITIAL C KITS - LATERAL PLATES Ref. Description CLD Clavicle kit - Lateral part - Size - Right CLG Clavicle kit - Lateral part - Size - Left INITIAL C - CLAVICLE KITS CONTENT - IMPLANTS QUANTITY PER KIT Ref. Description CLD/G CLD/G CBLD/G CTDLD or CTGLD Clavicle plate - Lateral part - Size - Right or Left - - CLD Clavicle kit - Lateral part - Size - Right CLG Clavicle kit - Lateral part - Size - Left CBLD Clavicle kit - Bendable - Lateral part - Size - Right CBLG Clavicle kit - Bendable - Lateral part - Size - Left INITIAL C KITS CONTENT - INSTRUMENTS Description CLxD/G CBLD/G T5 prehensor screwdriver Ø.7 mm threaded guide gauge for Ø3.5 mm screws Ø.7 mm quick coupling drill bit - L 0 mm Handle for guide gauge Length gauge for Ø.8 and Ø3.5 mm screws Pin Ø. L0 mm 3 3 T8 prehensor screwdriver Ø.0 mm threaded guide gauge for Ø.8 mm screws Ø.0 mm quick coupling drill bit - L 5 mm PLATES LOCKING SCREWS Ø.8 MM STANDARD CORTICAL SCREWS Ø3.5 MM LOCKING SCREWS Ø3.5 MM CTDLD or CTGLD CBTDLD or CBTGLD Clavicle plate - Lateral part - Size - Right or Left - - Bendable clavicle plate - Lateral part - Size - Right or Left - - SDT.8L0D Locking screw - Ø.8 mm - L 0 mm SDT.8LD Locking screw - Ø.8 mm - L mm SDT.8L4D Locking screw - Ø.8 mm - L 4 mm SDT.8L6D Locking screw - Ø.8 mm - L 6 mm SDT.8L8D Locking screw - Ø.8 mm - L 8 mm CT3.5LD Standard cortical screw - Ø3.5 mm - L mm CT3.5L4D Standard cortical screw - Ø3.5 mm - L 4 mm CT3.5L6D Standard cortical screw - Ø3.5 mm - L 6 mm CT3.5L8D Standard cortical screw - Ø3.5 mm - L 8 mm - SOT3.5LD Locking screw - Ø3.5 mm - L mm SOT3.5L4D Locking screw - Ø3.5 mm - L 4 mm SOT3.5L6D Locking screw - Ø3.5 mm - L 6 mm SOT3.5L8D Locking screw - Ø3.5 mm - L 8 mm 3

Initial C - References Additional kits Additional implants Sterile screws packaged in the Supplemental sterile screw caddy LOCKING SCREWS - Ø.8 mm * Ref. Description Qty SDT.8L0D-ST Locking screw - Ø.

8L8D-ST Locking screw - Ø.8 mm - L 8 mm - Sterile SDT.8L0D-ST Locking screw - Ø.8 mm - L 8 mm - Sterile SDT.8LD-ST Locking screw - Ø.8 mm - L mm - Sterile SDT.8L4D-ST Locking screw - Ø.

11 Initial C - References Additional kits Additional implants Sterile screws packaged in the Supplemental sterile screw caddy LOCKING SCREWS - Ø.8 mm * Ref. Description Qty SDT.8L0D-ST Locking screw - Ø.8 mm - L 0 mm - Sterile SDT.8LD-ST Locking screw - Ø.8 mm - L mm - Sterile SDT.8L4D-ST Locking screw - Ø.8 mm - L 4 mm - Sterile SDT.8L6D-ST Locking screw - Ø.8 mm - L 6 mm - Sterile SDT.8L8D-ST Locking screw - Ø.8 mm - L 8 mm - Sterile SDT.8L0D-ST Locking screw - Ø.8 mm - L 8 mm - Sterile SDT.8LD-ST Locking screw - Ø.8 mm - L mm - Sterile SDT.8L4D-ST Locking screw - Ø.8 mm - L 4 mm - Sterile * Non anodized. * Blue anodized. Removal kits Sterile instruments REMOVAL KITS Ref. Description Content REMOVE- Removal kit for T8 hexalobe T8 prehensor screwdriver REMOVE-3 Removal kit for T5 hexalobe T5 prehensor screwdriver Rescue kits Sterile instruments LOCKING SCREWS - Ø3.5 mm * Ref. Description Qty SOT3.5L0D-ST Locking screw - Ø3.5 mm - L 0 mm - Sterile SOT3.5LD-ST Locking screw - Ø3.5 mm - L mm - Sterile SOT3.5L4D-ST Locking screw - Ø3.5 mm - L 4 mm - Sterile SOT3.5L6D-ST Locking screw - Ø3.5 mm - L 6 mm - Sterile SOT3.5L8D-ST Locking screw - Ø3.5 mm - L 8 mm - Sterile SOT3.5L0D-ST Locking screw - Ø3.5 mm - L 0 mm - Sterile SOT3.5LD-ST Locking screw - Ø3.5 mm - L mm - Sterile SOT3.5L4D-ST Locking screw - Ø.8 mm - L 4 mm - Sterile STANDARD CORTICAL SCREWS Ø3.5 mm * Ref. Description Qty CT3.5L0D-ST Standard cortical screw - Ø3.5 mm - L 0 mm - Sterile CT3.5LD-ST Standard cortical screw - Ø3.5 mm - L mm - Sterile CT3.5L4D-ST Standard cortical screw - Ø3.5 mm - L 4 mm - Sterile CT3.5L6D-ST Standard cortical screw - Ø3.5 mm - L 6 mm - Sterile CT3.5L8D-ST Standard cortical screw - Ø3.5 mm - L 8 mm - Sterile CT3.5L0D-ST Standard cortical screw - Ø3.5 mm - L 0 mm - Sterile CT3.5LD-ST Standard cortical screw - Ø3.5 mm - L mm - Sterile CT3.5L4D-ST Standard cortical screw - Ø3.5 mm - L 4 mm - Sterile CT3.5L6D-ST Standard cortical screw - Ø3.5 mm - L 6 mm - Sterile * Light blue anodized. Templates INITIAL C TEMPLATES PLATE Ref. Description Qty ANC838 Midshaft and midshaft lateral clavicle plates templates ANC839 Lateral clavicle plates templates RESCUE KITS Ref. Description Content RESCUE- Initial C rescue kit for Ø.8mm screws - Ø.0 mm threaded guide gauge for Ø.8 mm screws - Ø.0 mm quick coupling drill bit - L 5 mm RESCUE-3 Initial C rescue kit for Ø3.5mm screws - Ø.7 mm threaded guide gauge for Ø3.5 mm screws - Ø.7 mm quick coupling drill bit - L 0 mm - Handle for guide gauge - Length gauge for Ø.8 and Ø3.5 mm screws - L 0-3 mm - Pin Ø. L0 mm (x3) The information presented in this brochure is intended to demonstrate a Newclip Technics product. Always refer to the package insert, product label and/or user instructions before using any Newclip Technics product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Newclip Technics representative if you have questions about the availability of Newclip Technics products in your area.

12 Cortical screws Ø3.5 mm Locking screws Ø3.5 mm 8 mm 6 mm 4 mm mm 0 mm 8 mm 6 mm 4 mm Non contractual pictures. mm 8 mm 6 mm 4 mm Locking screws Ø.8 mm 9 mm For Ø.8 mm screws For Ø3.5 mm screws For both Ø NEWCLIP USA 64 Larkfield Center Santa Rosa CA 95403, USA Phone : customerservice@newclipusa.com Brochure EN - Initial-C - Ed.3-0/08 - Medical devices: class IIb - CE 00 SGS UK - US Class: II - Read labeling and instructions before use. 4,5 mm Right Clavicle Superior Lateral Size 0 Example of kit content. mm CLD

Complex process High costs

MTP With a non sterile standard kit Calling on medical staff Constraints Complex traceability Contracted out sterilization Suppliers deadline Complex process High costs 1 Delivery 2 Storage 3 Unpacking