Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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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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Device returned with packaging damage and sterility barrier compromised.
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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 found the inner sterile packaging and outer cartons are damaged.Sterility has been compromised.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.The likely condition of the product when it left zimmer biomet control was conforming to specifications.The root cause is attributed to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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