The returned instrument, intended for use in treatment, was returned for evaluation.There was no relationship found between the device and the reported incident.Visual inspection of the q-fix all suture anchor 2.8mm show a deployed instrument and the implant is missing.Visual inspection shows no manufacturing abnormalities on the device.No drill/drill guide and no disposable kit were returned with the instrument.The device is a single used device and could not be functional tested.The complaint was not verified, as the device was used and deployed.The q fix suture anchor was pulled out of the hole.An exact root cause cannot be determined with confidence; however, factor unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) bone quality.(2) drilled bone hole size.Poor bone quality or oversized drilled bone hole can result in damage to the device and device failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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