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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Zimmer biomet complaint (b)(4).The customer has returned the device for evaluation.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 an instrument fractured during a dental procedure.The fractured piece of the instrument was removed from the patient by suction and the procedure was completed with a back-up instrument.No adverse events were reported as a result of this 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 and the tip had fractured off.The dhr was reviewed and there were no nonconformance's found.There are no indications of manufacturing defects.This is the only complaint regarding the tip fracturing for this part 09-0258 lot number 071318f18.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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