(b)(4).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.(b)(4).Event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04446, 0001822565 - 2018 - 04447, 0001822565 - 2018 - 04448, 0001822565 - 2018 - 04449, 0001822565 - 2018 - 04450, 0001822565 - 2018 - 04452, 0001822565 - 2018 - 04453, 0001822565 - 2018 - 04455, 0001822565 - 2018 - 04456, 0001822565 - 2018 - 04457, 0001822565 - 2018 - 04458, 0001822565 - 2018 - 04459, 0001822565 - 2018 - 04460, 0001822565 - 2018 - 04461, 0001822565 - 2018 - 04462, 0001822565 - 2018 - 04463, 0001822565 - 2018 - 04464, 0001822565 - 2018 - 04465, 0001822565 - 2018 - 04466, 0001822565 - 2018 - 04467.
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It was reported that during incoming inspection at the warehouse, there was a stain found on the product.There were no adverse events as a result of this malfunction, as there was no patient involvement.Attempts have been made and no further information has been provided.
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This follow-up report is being submitted to relay additional information.Reported stains were confirmed by visual examination.It was determined the stain was 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.No product problem has been identified and the devices conform to their specifications.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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