Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that the inner sterile package was damaged.Additional information on the reported event is unavailable.
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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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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.The visual inspection of the returned product identified that the sterile cavity was damaged.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.This product falls within the scope of a corrective action that is reviewing all the packaging configurations at zimmer biomet, (b)(4).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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Search Alerts/Recalls
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