H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed and the displacement was confirmed.The clinical/medical investigation concluded that, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported screw displacement could not be determined, as it was reported that the shell had the desired press-fit and had no risk of migration.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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, traumatic injury or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.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.
|