(b)(6).This report is number 15 of 18 mdr supplementals filed for the product (reference 0001822565-2017-05039, 0001822565-2017-05040, 0001822565-2017-05041, 0001822565-2017-05042, 0001822565-2017-05043, 0001822565-2017-05044, 0001822565-2017-05046, 0001822565-2017-05047, 0001822565-2017-05048, 0001822565-2017-05049, 0001822565-2017-05050, 0001822565-2017-05051, 0001822565-2017-05052, 0001822565-2017-05053, 0001822565-2017-05055, 0001822565-2017-05056, 0001822565-2017-05057) expiry date on packaging - sep 1, 2017.Lot number 56613801 on instrument; lot number 56613800 on label.(b)(6).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.
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Complaint sample was evaluated and the reported event was confirmed.Investigation found that the parts became unintentionally mixed during the incoming inspection, as inspector did not properly separate and segregate the materials and the inspection procedure does not define how to properly segregate and control material during the inspection process.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.The root causes for the reported issue attributed to be quality system deficiency and device not manufactured by reporting firm as the device manufactured by the supplier.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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