(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05980, 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, 0001822565-2018-05998, 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.
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There was no issue found with the product.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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.
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Report source foreign ¿ (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified that 13 pieces from lot # 64053676, 11 were found conforming and two pieces failed.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.Corrective actions have been initiated to address this issue.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.
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