Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).For section e1, the surgeon in this case is unknown as it could be any of the following: dr.(b)(6), dr.(b)(6), dr.(b)(6).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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It is reported that the elevator fractured during a procedure.There were no injuries or delays with all fractured pieces accounted for and returned.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned elevator.The elevator shows signs of multiple uses including marking/ scratching on the elevator surface.The inspection also showed that the tip has fractured.The fractured tip was not returned.A determination cannot be made as to what caused the tip to fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed as returned product is fractured.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 is available at the time of this report.
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Search Alerts/Recalls
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