(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.
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Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.The reported event has been addressed as part of previous investigations after complaints were received reporting that the blisters were cracking.It was determined that thin/variable blister wall thickness and no head-space in the shelf carton were causing the blister to deform and crack during distribution.The packaging design configuration was changed to address this issue.Therefore, the root cause is related to design deficiency.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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