(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Product was returned with the packaging in an opened condition; the tyvek on the outer cavity has been partially pulled open and is still attached to the thermal cavity, with evidence of proper sealing of the lid in the form of dry glue completely covering the exposed sealing edge.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.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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