Zimmer biomet complaint: (b)(4).Concomitant medical products: medical products.Item#: 76-26020, lot#: unk, ribfix blu 12 hole prebent plt.Item#: 76-2410, lot#: unk, ribfix blu scr s/d-lk 2.4x10mm.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00038, 0001032347-2023-00018.
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identifications were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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