This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g7, h1, h2, h10 visual inspection of the returned device identified the tip of the nitinol pusher has been fractured off.The piece that was fractured was not returned.Suture and needle do appear to be intact.The anchor is frayed from attempted implantation.Device history record 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.
|