(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05438, 0001822565-2019-00787, 0001822565-2019-00788, 0001822565-2019-00791, 0001822565-2019-00792, 0001822565-2019-00794, 0001822565-2019-00795, 0001822565-2019-00797, 0001822565-2019-00798, 0001822565-2019-00799, 0001822565-2019-00800.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the eighteen (18) products returned identified only eleven (11) products confirmed the presence of crease and/or fold in the seal of the pouches.Device history record was reviewed and no discrepancies were found.Manufacturing deficiency is considered as the root cause of the reported issue and corrective action is being conducted.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.
|