Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).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.Expected, not yet received.
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Event Description
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It was reported during incoming inspection at the warehouse, that it was discovered there was a crease in the sealing area.There was no patient involvement.
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Event Description
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No additional information received.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was not confirmed; review of the packaging determined that no failure was found as the product is within specification.Dhr was reviewed and no discrepancies were found.The device analysis indicated that the device met 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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