This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d4, g3, g6, h1, h2, h3, h4, h6, h10 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the guide rod shows signs of use with some scratches around the lot information, the guide rod has also fractured and not all of the pieces were returned.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies 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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