(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00358, 0001032347-2021-00359, 0001032347-2021-00360, 0001032347-2021-00362.Concomitant medical products: item# 73-2643; lot# 632920.Item# 73-2643; lot# 640200.Item# 73-2418; lot# 616700.Item# 73-2418; lot# 616700.Report source: foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital discarded the device as a biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined for the reported screws falling out.These devices are provided non-sterile and the user is responsible for sterilization.Therefore, it is unlikely that these devices caused or contributed to any patient infection.If any further information 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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