The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the poly ring did not fit correctly, so the surgeon impacted it.During the impaction, a small piece in the ring was damaged.There was no backup device available, therefore the damaged ring was left implanted.It is unknown whether there is any future plan for revision or intervention, as the requested information has not been provided.Therefore the patient impact cannot be determined at this time.Should additional relevant clinical documentation become available, the clinical/medical task may be re-opened.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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