Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: 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 mdr will be submitted.
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Event Description
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It was reported that during a revision procedure the lcck locking screw fractured.During the procedure there was a delay of greater than 30 minutes.Attempts have been made and no further information has been provided.
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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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Complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.Per package insert: fracture is a known adverse cause of the system.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified locking screw was fractured.Device was submitted for further analysis.Analysis determined device experienced torsional overload failure.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Per package insert, fracture is a known adverse cause of the system.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 at time of this report.
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Search Alerts/Recalls
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