(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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02735.
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This follow-up report is being submitted to relay additional information.The following sections were updated: a1, b4, b5, g4, g7, h2, h6, h10.Visual examination of the returned product identified indentation damage on black tip.Function check was done and the device functioned properly however the device does have some resistance when removing gage.No further measurements done as the black poly tip is damaged.Stem not returned.Part and lot identification are necessary for review of device history records, neither were provided for stem.A definitive root cause cannot be determined.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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