(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05980, 0001822565-2018-05981, 0001822565-2018-05983, 0001822565-2018-05985, 0001822565-2018-05986, 0001822565-2018-05988, 0001822565-2018-05989, 0001822565-2018-05990, 0001822565-2018-05992, 0001822565-2018-05993, 0001822565-2018-05995, 0001822565-2018-05996, 0001822565-2018-05999, 0001822565-2018-06001, 0001822565-2018-06002, 0001822565-2018-06003, 0001822565-2018-06004, 0001822565-2018-06006, 0001822565-2018-06008, 0001822565-2018-06010, 0001822565-2018-06011, 0001822565-2018-06012, 0001822565-2018-06014, 0001822565-2018-06015.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
|
Report source foreign ¿ (b)(6).Visual examination of the returned products identified that 13 pieces from lot # 64053676, 11 were found conforming and two pieces failed and 12 pieces from lot # 64021728 were found to be conforming.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.The event is being processed through the capa process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|