Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product is not returned to zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It is reported that a different device was discovered in the package than what the label indicated should be in the box.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Multiple mdr reports have been reported for this event, please see associated report: 0001825034-2018-03593.Complaint is confirmed as this part and lot combinations are recalled however we did not receive the products.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency as it is likely that the products were comingled during cleaning prior to laser etch.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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Event Description
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It is reported that a different device was discovered in the package than what the label indicated should be in the box.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
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Search Alerts/Recalls
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