(b)(4).Report source: foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02498.Visual evaluation of the returned product found the seals do not meet the minimum requirement and are non- conforming.Sterility has been compromised.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The 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 work instructions provided.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.
|