(b)(4).Concomitant medical products: catalog#: 51-104140, tprlc, 133, t1, pps, ho, 14x148mm, 8mm, t1, lot#: 6127286.Catalog#: 51-107130, tprlc, 133, mp, type1, pps, ho, 13.0, m, t1, lot#: 3466844.Catalog#: 51-106140, tprlc, 133, mp, type1, pps, so, 14.0, 1, lot#: 3899136.Report source: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05789, 0001825034-2019-05790, 0001825034-2019-05791.
|
This follow-up report is being submitted to relay additional information.Udi#: (b)(4).The event is confirmed with product received.Evaluation of the returned product confirmed the sterile packaging (pouch/ blister and pouch) is damaged.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event it likely to be damage during transit.A corrective action was opened to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this action, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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.
|