This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g7, h1, h2, h3, h6, h10.Visual evaluation of the returned product found the packaging is confirmed to be sealed.No damage noted.The packaging is not completely tight against the part.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.
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