(b)(4).Medical products - ni, unknown k-wire, ni.131812051, dvr lock standard r st, unknown.131827112, lock screw sq 2.7mm 12mm ste, unknown.131827112, lock screw sq 2.7mm 12mm ste, unknown.131827112, lock screw sq 2.7mm 12mm ste, unknown.131827116, lock screw sq 2.7mm 16mm ste, unknown.131827116, lock screw sq 2.7mm 16mm ste, unknown.131827118, lock screw sq 2.7mm 18mm ste, unknown.131827114, lock screw sq 2.7mm 14mm ste, unknown.Report source, foreign ¿ events occurred in (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.
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.K wire was not returned; however, a portion of the k wire was found embedded in the returned plate's corresponding hole.Therefore, the complaint is confirmed for a fractured k wire.The plate shows minor cosmetic damage, likely from the attempt to implant it.Dhr was reviewed and no discrepancies were found.Review of complaint history determined that no further action is required.Implant compatability could not be assessed without product id of the k-wire.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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