Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned products identified that there is debris inside the sterile packages.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was attributed to manufacturing deficiency.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03520 - 1, 0001825034 - 2018 - 03521 - 1.
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