Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 the elevator fractured during a procedure.No adverse events have been reported as a result of the malfunction.
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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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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.The product identity was confirmed.The elevator was visually evaluated.The elevator showed signs of moderate use with scratches on the handle.It was also clear that the distal end was fractured.The device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the instrument experienced excessive force, beyond what it was designed to encounter.There are no indications of manufacturing defects.The instructions for use (ifu) for this instrument states in the section titled 'warnings and precautions': avoid undue stress or strain when handling or cleaning instruments.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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