(b)(4).Source: (b)(6).Multiple reports were reported along with this report: 0001825034-2021-02216, 0001825034-2021-02217, 0001825034-2021-02218, 0001825034-2021-02219, 0001825034-2021-02220.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.Evaluation of the returned product confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.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 likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the provided work instructions during manufacturing.The work instruction for the operation where the manufacturing deviation is likely to have occurred was reviewed and found to be adequate information informing the operator to inspect packaging for foreign material inside the sterile packaging.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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