(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01939, 0001825034-2020-01940, 0001825034-2020-01942, 0001825034-2020-01944, 0001825034-2020-01945.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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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h4, h6, h10.Evaluation of the returned product/photographs provided confirmed debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies were found.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is due to transit damage causing the foam packaging to become abraded and shed.This device falls within the scope of a corrective action which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this corrective 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.Upon investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided 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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