(b)(4).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.Concomitant medical products: cannulated drill with stop 6 mm, catalog: 47430706100, lot: 65092392.2.5mm pin, catalog: 47430902501, lot: 65038433.2.5mm drill, catalog: 47430904601, lot: 65157512.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00274, 0009613350-2022-00275.
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This follow-up report is being submitted to relay additional and/or corrected information.As neither the products nor any images of the products were received, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The devices are used for treatment.Medical records were not provided.A definitive root cause related to the reported pain and lack of range of motion 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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