Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 was reported the instrument broke.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.Visual evaluation showed signs of use as there was minor scratching on the body of the elevator.Further evaluation showed that the tip had fractured off.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.(b)(4).The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.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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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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