Replacing the Shear Pin:
Some instruments with actuating loop handles contain a shear pin that connects the
handle to the central operating rod. The shear pin is designed to fail prior to a more
serious failure mode, such as the jaws breaking apart from excessive force. If the shear
pin breaks, contact Stryker for repair or replacement.
Fragment Removal:
In the rare event of instrument breakage, fragments can be located visually or by use
of radiographic imaging equipment. Fragments can be removed manually through the
incision site.
Reprocessing:
These reprocessing instructions are provided in accordance with ISO 17664. While they
have been validated by the manufacturer of the medical device as being capable of
preparing the device for re-use, it remains the responsibility of the processor to ensure
that the reprocessing as actually performed, using equipment, materials, and
personnel in the reprocessing facility, achieves the desired result. This normally
requires validation and routine monitoring of the process.
Limitations on Reprocessing:
1. Repeated processing has minimal effect on instrument life and function. End of
useful instrument life is generally determined by wear or damage from handling
or surgical use.
2. Do not leave the instruments in solutions longer than necessary, as this may
accelerate normal product aging.
3. Damage incurred by improper processing will not be covered by the warranty.
Containment and Transportation:
1. Reprocess the device as soon as reasonably practical following use.
2. Transport the device in an appropriate manner to prevent damage.
Warnings:
1. The following cleaning, disinfection and sterilization methods have been validated.
Failure to follow reprocessing instructions as provided may result in incomplete
decontamination.
2. Wear appropriate protective equipment (gloves, eye protection, etc.).
3. The Suture Cutter must be disassembled prior to cleaning, disinfection, and
sterilization, or incomplete decontamination will result.
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