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 05/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that the end of the pin driver broke while the surgeon was screwing into the block.It was noted that the patient had extremely hard bones.A different driver was used to complete the case.There was no consequences or impact to the patient.
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Manufacturer Narrative
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(b)(4).The 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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product found that the product exhibits signs of repeated use and the hex feature has fractured.All pieces were returned.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause is attributed to standard wear and tear from repeated use for 10+ years.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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