Model Number N/A |
Device Problem
Packaging Problem (3007)
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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 was returned with packaging damage, which compromised sterility barrier.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product found the carton is crushed near the perforation, and the perforation is opened.Both inner and outer cavities are cracked and crushed.The sterility has been compromised.The complaint is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue 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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