(b)(4).Report source: (b)(6).Multiple reports were submitted along with this report 0001825034-2021-02994, 0001825034-2021-02995, 0001825034-2021-02996, 0001825034-2021-02997, 0001825034-2021-02999, 0001825034-2021-03000, 0001825034-2021-03001.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.Visual evaluation of the returned product/photographs provided identified damage to sterile blister with debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating.Complaint sample was evaluated and the reported event was confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.Corrective actions has been previously raised to implement improved packaging changes.These packaging changes will reduce the number of transit related packaging damage events.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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