(b)(4).Additional concomitant medical products: 00151603044, impactor, 62989802; 00151603044, impactor, 63148869; 00151603032, impactor, 61889511; 00151603048, impactor, 63243101.(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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 07812, 0001822565 - 2017 - 07811, 0001822565 - 2017 - 07815, 0001822565 - 2017 - 07816.
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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.As returned, the maxera cup impactors exhibit wear & tear to the connecting features.All the 5 devices have cracks on the cap and have metal particles embedded on the dome, dimensional measurements are conforming to print specifications.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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