Collinear Reduction Clamp Instructions for Use

Instructions for Use Collinear Reduction Clamp

Device(s) in scope: 314.291 398.752 398.753 398.754 398.756 398.757 398.758

Introduction The Collinear Reduction Clamp assists in achieving and maintaining fracture reduction in minimally invasive techniques. The Collinear Reduction Clamp consists of a sliding mechanism, attachable arms and reduction attachments. To create a clamp, the sliding mechanism is used with an attachable arm. The following arms are currently available: –– Hohmann-shape Arm (398.752) –– Pelvic Arm (398.753) –– Percutaneous Arm (398.754) –– Bone Hook-shape Arm (398.756). To aid in reduction against plates, the following reduction attachments are available: –– LCP Reduction Attachment (398.757) –– Reduction Attachment (398.758). The Collinear Reduction Clamp is used for long bone, articular and pelvic fracture types. Important note for medical professionals and operating room staff: These instructions for use do not include all the information necessary for selection and use of a device. Please read the instructions for use and the Synthes brochure “Important Information” carefully before use. Ensure that you are familiar with the appropriate surgical procedure.

Intended Use Reduction instruments are intended for lifting up or repositioning bone fragments and soft tissues during surgery.

Indications Synthes manufactures surgical instruments intended to prepare the site and aid in implantation of Synthes implants. The indications / contraindications are based upon the implant devices rather than the instruments. Specific indications / contraindications for the implants can be found in the respective Synthes implant instructions for use.

Contraindications Synthes manufactures surgical instruments intended to prepare the site and aid in implantation of Synthes implants. The indications / contraindications­ are based upon the implant devices rather than the instruments. Specific indications / ­ contraindications for the implants can be found in the respective Synthes implant instructions for use.

Expected Clinical Benefits Synthes manufactures surgical instruments intended to prepare the site and aid in implantation of Synthes implants. The clinical benefits for the instruments are based upon the implant devices rather than the instruments. Specific clinical ­benefits for the implants can be found in the respective Synthes implant instructions for use.

Performance Characteristics of the Device Synthes has established the performance and safety of Collinear Reduction Clamps and that they represent state of the art medical devices for placement of an internal orthopaedic fixation system into or onto all types of bones when used according to their instructions for use and labeling.

Potential Adverse Events, Undesirable Side Effects and Residual Risks Synthes manufactures surgical instruments intended to prepare the site and aid in implantation of Synthes implants. The adverse events / side effects are based upon the implant devices rather than the instruments. Specific adverse events / side ­effects for the Implants can be found in the respective Synthes implant instructions for use.

Warnings and Precautions For general warnings and precautions, consult the Synthes brochure “Important Information”. There are no specific warnings and precautions related to Collinear Reduction Clamp.

Combination of Medical Devices Synthes has not tested compatibility with devices provided by other manufacturers and assumes no liability in such instances.

Treatment before Device is Used Synthes products supplied in a non-sterile condition must be cleaned and steam-sterilized prior to surgical use. Prior to cleaning, remove all original packaging. Prior to steam-sterilization, place the product in an approved wrap or container. Follow the cleaning and sterilization instruction given by the Synthes brochure “Important Information”.

Troubleshooting Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and / or patient is established.

Clinical Processing of the Device Detailed instructions for processing of implants and reprocessing of reusable devices, instrument trays and cases are described in the Synthes brochure “Important Information”. Assembly and disassembly instructions of instruments “Dismantling multipart instruments” are available on the website.

Disposal Devices must be disposed of as a healthcare medical device in accordance with hospital procedures.

Patient Target Group Synthes manufactures surgical instruments intended to prepare the site and aid in implantation of Synthes implants. The patient target group is based upon the ­implant devices rather than the instruments. Specific patient target group for the implants can be found in the respective Synthes implant instructions for use.

Intended User This IFU alone does not provide sufficient background for direct use of the device or system. Instruction by a surgeon experienced in handling these devices is highly recommended. This device is intended to be used by qualified health care professionals e.g. surgeons, physicians, operating room staff, and individuals involved in preparation of the device. All personnel handling the device should be fully aware of the IFU, the surgical procedures, if applicable, and / or the Synthes “Important Information” brochure as appropriate.

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Special Operating Instructions

2. Reduction attachment: 3

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Note: Watch the sharp tip of the attached arm.

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Mount the reduction attachment like shown. Align the two legs of the attachment to the flat surfaces of the feed rod. Start in a 90 degrees angle from below and slide the reduction attachment over the tip of the feed rod. The attachment clicks into place as soon as it is in the right position. Secure the reduction attachment by screwing down the sleeve.

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1 Pelvic Arm 2 Release button 3 Feed rod 4 Trigger 5 Release lever 6 Synthetic screen 7 Hohmann-style Arm 8 Percutaneous Arm 9 Spiked Disc 10 Bone Hook-shape Arm 11 LCP Reduction Attachment 12 Reduction Attachment

Handling: 1. Arm attachment / removal: Select an attachment arm and slide it over the feed rod. Press the release button and mount the arm onto one of the mounting notches. An arm can be repositioned by pressing the release button and rotating the arm to engage a different notch. Remove the attachment arm by pressing the release button and sliding the arm off the notch.

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Release button For disassembly, first unscrew the sleeve of the reduction attachment either by hand or by using the combination wrench B 13 mm. Then push the release lever and pull back the feed rod until the reduction attachment falls off.

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Care and Maintenance: Before cleaning and sterilization, remove any attachment from the sliding mechanism (arm, reduction attachment and spiked disc) and remove the synthetic screens from the sliding mechanism. Clean the cannulated feed rod manually, using a 2.9 mm cleaning brush. Never dismantle the sliding mechanism itself. Its construction allows impeccable cleaning without disassembly. Lubricate the movable parts (clamp spring of the sliding mechanism, couplings of attachment arms etc.) of the Collinear Reduction Clamp after each use with autoclavable Synthes oil. After oiling, push the button on the attachment coupling and slide the feed rod several times to ensure proper distribution of the oil.

Before cleaning and sterilization, close the reduction attachment either by hand or by using the combination wrench B 13 mm.

3. Reduction / Release: Squeeze the trigger to advance the feed rod and reduce the bone fragments. Note: Continued advancement of the feed rod may generate excessive clamping forces. A spiked disc to help distribute the compressive forces is available (particularly on poor quality bone). The spiked disc can either be mounted on the tip of the percutaneous arm or on the tip of the feed rod.

To help holding the tip of the LCP reduction attachment, use the combination wrench B 8.0 mm.

To release the clamp, press the release lever and manually retract the feed rod. Note: Do not squeeze the trigger while pressing the release lever, as this will not allow the feed rod to slide freely.



Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 www.jnjmedicaldevices.com

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