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 10/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that the instrument fractured 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).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 identified signs of use (nicked/gouged) and the device was found to have a portion fractured off, with all pieces returning.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The device has a potential field age of over 5 years and exhibit signs of repeated use.The root cause of the reported event is attributed to wear and tear from repeated use over time.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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