The device was received at the manufacturer for testing.An evaluation was conducted and the investigation results show that the postoperative plate fracture occurred through a fixing hole, so the reported event could be confirmed.No lot number was provided, thus a review of the specific manufacturing batch records and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.
|