Catalog Number 406113 |
Device Problem
Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: (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 report will be submitted.
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Event Description
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It was reported that the trial fractured during the procedure.No foreign body was left in the patient.Attempts have been made and additional information on the reported event is unavailable.
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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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This follow-up report is being submitted to relay additional information.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Manufacturer Narrative
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Visual inspection of the returned device identified one of the peg had fractured and was not returned for evaluation.The device has nicks, scratches, wear likely from usage.The device has 7 years of field service age and it is unknown how many times the device was used.The root cause remains the same.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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