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 Date 10/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint: (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 tip of the instrument fractured during a procedure resulting in a 30 minute delay due to an x-ray being taken to search for fractured pieces.No fractured pieces of the instrument were found in the patient.No adverse events have been reported as a result of the malfunction.
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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.This is the only complaint in regards to an instrument fracture for 09-0258 lot 100516i16.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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