Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
|
Additional information in b4, d4 (udi), d10, device availability, g4, g7, h2, h3, h4, h6: methods, results, and conclusion codes.The specified identity of the device was confirmed and the device was examined.Visual inspection revealed the tip has fractured off.The device history record (dhr) was reviewed.There were no nonconformances or temporary deviations associated with this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.It was reported that during the procedure the tip of the tap broke.The complaint is confirmed.The exact cause of this event can't be determine with the available information.
|