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 Date 04/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01840.
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Event Description
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It was reported that during stock investigation at the warehouse, the inner pouch was torn.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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Complaint sample was returned and evaluated against the reported event.Evaluation of the returned products provided confirmed the sterile packaging (blister) is damaged.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is likely due to damage during transit.The likely condition of the device when it left zimmer biomet is conforming to specification.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable event.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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