(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01980, 0001825034-2020-01981, 0001825034-2020-01982, 0001825034-2020-01983, 0001825034-2020-01984.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.Visual inspection confirmed white debris within the sterile packaging.The insert has been damaged such that particles have become detached and float freely within the sterile packaging.The blister seal remains intact.The outer packaging is roughened through handling but no notable damage was observed.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 attributed to transit damage causing the porous coating to shed from the implant.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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