(b)(4).0001822565 - 2018 - 04135, 0001822565 - 2018 - 04136, 0001822565 - 2018 - 04137, 0001822565 - 2018 - 04138, 0001822565 - 2018 - 04134, 0001822565 - 2018 - 04140.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h6, h10 multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04135 -1, 0001822565 - 2018 - 04136 -1, 0001822565 - 2018 - 04137 -1, 0001822565 - 2018 - 04138 -1 and 0001822565 - 2018 - 04140 -1.The complaint sample was returned and evaluated and the reported event was confirmed through physical evaluation.The missing components were not returned.The device history records were reviewed and no discrepancies were identified.Investigation results concluded that the reported event was due to design issue.Field actions were initiated to recommend against using ultrasonic cleaning as a sterilizing technique for these devices.The device was subsequently re-designed to account for this failure mode with a new locking mechanism.It was determined that this device was manufactured prior to this design change.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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