The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured at the angled screw hole on the proximal end.The threads in the screw hole were heavily damaged.Both pieces were returned.The clinical / medical investigation concluded that, although requested, no images (x-rays or mri) or surgical reports were provided for review.Per report a revision surgery was performed due to a broken nail caused by non-union.It was communicated that the patient is doing good following the procedure.No further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a non-union.Based on this investigation, the need for corrective action is not indicated.Should 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.
|