This follow-up report is being submitted to relay additional information.The complaint sample was evaluated, and the reported event was confirmed.Visual inspection of returned product determined that the outer tyvek lid shows evidence that a seal existed along the entire perimeter of the outer tyvek cavity.Review of the inner cavity shows that the corner of the tyvek lid has begun to peal off of the blister cavity.The corner that is peeled back show evidence that a seal existed between the tyvek lid and the blister cavity.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The root cause of the reported event is a manufacturing deficiency as the breach in the seal was likely caused by either the foam pushing on the seal and forcing it open or by the inner seal being breached when the outer seal was opened.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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