This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The device was returned and evaluated against the complaint.Upon return, the tip of the inserter is fractured.Dhr (device history record) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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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