(b)(4).D10: unk plate cat#ni lot#ni, unk screw cat#ni lot#ni, unk screw cat#ni lot#ni, unk screw cat#ni lot#ni.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: 01032347 - 2023 - 00376, 01032347 - 2023 - 00377, 01032347 - 2023 - 00379, 01032347 - 2023 - 00380.
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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.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The reported event is unconfirmed.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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