Model Number N/A |
Device Problems
Device Markings/Labelling Problem (2911); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).This report is number 18 of 18 mdr supplementals filed for the product (reference 0001822565-2017-05039 0001822565-2017-05040 0001822565-2017-05041 0001822565-2017-05042 0001822565-2017-05043 0001822565-2017-05044 0001822565-2017-05046 0001822565-2017-05047 0001822565-2017-05048 0001822565-2017-05049 0001822565-2017-05050 0001822565-2017-05051 0001822565-2017-05052 0001822565-2017-05053 0001822565-2017-05054 0001822565-2017-05055 0001822565-2017-05056 0001822565-2017-05057).Expiry date on packaging - sep 1, 2017; lot number 56613801 on instrument; lot number 56613800 on label.(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.
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Event Description
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It was reported the lot number was inconsistent between package and product.No patient consequences or involvement were reported as a result of the malfunction.Attempts to obtain additional information are in progress, however no further information is available at this time.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Investigation found that the parts became unintentionally mixed during the incoming inspection, as inspector did not properly separate and segregate the materials and the inspection procedure does not define how to properly segregate and control material during the inspection process.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.The root causes for the reported issue attributed to be quality system deficiency and device not manufactured by reporting firm as the device manufactured by the supplier.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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Manufacturer Narrative
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The follow-up report is being submitted to relay additional information.Device manufacture date: aug 23, 2015 or oct 2, 2015.
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Search Alerts/Recalls
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