Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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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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Product was returned with sterility barrier potentially 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 outer box shows that the original shrink wrap is not present with a damaged carton.The damage to the carton is within acceptable limits per cosmetic requirements for inbound and outbound shipments.The product was received with the inner pouch opened likely by the customer.Complaint sample was evaluated and the reported event was confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is conforming to specification.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 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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