(b)(4).Foreign - (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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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(b)(4).This follow-up report is being submitted to relay additional information.Udi # (b)(4).Reamer guide item # unknown lot # unknown.Initial reporter name/address: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04507.Complaint sample was evaluated and the reported event was not confirmed.Visual evaluation of the returned patella reamer shows nicks and gouges indicating the sign of use.The measured dimension of the pilot holes was conforming to print.The 2 tabs were bent and causes to fail the reamer blade overall diameter max positioning test.However, while performing the slot functional test, the instrument passed.A review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The damaged/bent tabs in the reamer bladed show the damages might be caused during the mating process and causes the mating issue.But, sufficient information was not provided to support this claim as mating instrument used in procedure was not returned.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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