This event was initially reported under mfr# : 0009613350 -2021 -00301.Event date: unknown day in (b)(6) 2021.Implant date: unknown day in (b)(6) 2020.Concomitant products: cat: 814510100 lot: wg1111300a hfn lag screw 10.5mm x 100mm.Cat: unknown screw lot: unknown.Cat: unknown screw lot: unknown.Report source: foreign- (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00848, 0001825034 - 2022 - 00849, 0001825034 - 2022 - 00850.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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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, 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 that the nail is fractured.Fracture analysis was done on the nail and fatigue fractures were identified.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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