This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4, g3, h2, h3, h4, h6.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of the porous coating inside the sterile barrier.The sterile pouch was torn.Packaging was returned opened, therefore, the sterility of the device cannot be determined.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event can be attributed to transit damage and packaging design deficiency.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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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