Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(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 report will be submitted.
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Event Description
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It was reported that debris was found in the sterile package.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual inspection of the returned product identified a hair-like debris within the sealed sterile packaging.The complaint is confirmed.Ftir spectrum analysis of the debris concluded it is a biological material and the appearance suggests hair.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to operator error during the manufacturing process.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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