(b)(4).Concomitant medical products: oxf twin-peg cmntd fem sm pma item# 161468 lot# 674360; oxf anat brg rt sm size 3 pma item# 159568 lot# 863520.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: 3002806535 - 2022 - 00450; 3002806535 - 2022 - 00451; 3002806535 - 2022 - 00452.
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(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10 no products were returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Radiographs were provided, and images are not being sent to mmi at this time due to poor image quality.A mmi assessment would not enhance the investigation.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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