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 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Customer has not indicated that the product will be returned to zimmer biomet for investigation.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 product fractured during impaction.No harm was done to the patient.The surgery was finished without any problem.There is no additional information at this time.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.The reported event is considered confirmed.Product was returned and visual examination of the returned proximal femoral impactor identified signs of repeated use (nicked or gouged) and is cracked.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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