Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the instrument broke during trialing.The surgical technique was utilized.There was no surgical delay.No foreign bodies were retained.No known impact or consequence to the patient.Attempts have been made and no further information has been provided.
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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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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.H6 : proposed component (annex g) code is mechanical (g04) - provisional bottom.Performed a visual inspection of the provided photographs as the device wasn¿t returned and found it to exhibit signs of repeated use, nicked / gouged is fractured on the lateral side of the post, and the post feature has fractured off.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.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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