Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 mdr will be submitted.
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Event Description
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It was reported that the internal packaging was compromised.Distribution center has implant with packaging to return.Attempts were made to obtain additional information; however, none was available.
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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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(b)(4).Reported event was confirmed by visual inspection of the returned product.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the reported issue is attributed to transit damage.The likely condition of the product when leaving zimmer biomet was conforming to specifications.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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