(b)(4).Concomitant medical products- unknown screw.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-001127.
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Zimmer biomet complaint (b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-001127-1.The product relating to the reported event has been returned to biomet uk ltd for evaluation.The returned hiploc plates have been confirmed as non-conforming.The internal barrel on the hiploc plate has been confirmed as undersize through dimensional checks.A review of the manufacturing history records for the hiploc plate from this event has not reported any abnormalities or deviations.13 complaints were previously recorded for this reported issue.A supplier corrective action report, scar- 01951, has been raised on sanatmetal to investigate their manufacturing processes in relation to the non-conformance.Product hold has been initiated: ph-2018-00225-emea a corrective and preventative action, ca-04598 has been raised to investigate receipt and release of product.A health hazard evaluation has been completed (hhe-2018-00210), resulting in a field action determination: zfa-2018-00210.
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