(b)(4).Complaint sample was evaluated and the reported event was confirmed.Evaluation of returned device found opened supplier inner sealing.The manufacturer inner sealing was not damaged.The outer packaging was not damaged.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to supplier packaging issue.Corrective action has been initiated to address reported issue.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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