(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05809, 0001822565-2018-06016, 0001822565-2018-06017, 0001822565-2018-06019, 0001822565-2018-06020, 0001822565-2018-06021, 0001822565-2018-06022, 0001822565-2018-06023, 0001822565-2018-06024, 0001822565-2018-06025, 0001822565-2018-06026, 0001822565-2018-06027, 0001822565-2018-06028, 0001822565-2018-06029, 0001822565-2018-06030, 0001822565-2018-06031.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.Product not returned.
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This follow-up report is being submitted to relay additional information.Udi # - (01) 00889024094780.Report source - foreign - japan.Complaint sample was evaluated and the reported event was confirmed.The stains are caused by the way the tear drop guide wires are fixtured during passivation.The guide wires are placed on a rack with two or more contact points.These contact points cause a small portion of the guide wire to not receive a full passivation coating, leading to an inconsistent coating appearing as a "stain" or mark.These stains are not corrosion, and do not impact the fit, form, or function of the guidewires; they are merely cosmetic.The product is conforming per zimmer biomet's criteria.Device history record was reviewed and no discrepancies were found.The root cause is determined as no device issue identified.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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