(b)(4).Foreign report source: (b)(6).Evaluation of the returned product/photographs provided confirmed the sterile packaging blister is damaged for lot #6360462.Further evaluation found debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier, and foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.Sterility has been breached.Therefore, the reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the foreign debris is the operator not following the work instructions provided.The root cause of the white foam debris and blister damage is likely due to transit damage.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.
|