The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: -before using the fast-fix meniscal knot pusher and suture cutter, pull the free end of the fast-fix suture, advancing the sliding knot, reducing the meniscal tear- while holding the suture taut, advance the knot pusher and suture cutter device to remove any remaining suture laxity- with the tip of the knot pusher and suture cutter device resting on the knot, slide the gold button to cut the suture.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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