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).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 that the instrument fractured at the tip during a procedure.A back-up was used to complete the procedure.No adverse events were reported as a result of the malfunction.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A visual inspection could not be conducted due to the product being lost after being delivered to jacksonville.Lot identification is necessary for review of device history records, lot identification was not provided.A supplier dhr review requested was not made as the lot number is unk.A definitive root cause cannot be determined.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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Search Alerts/Recalls
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