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 02/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has not indicated whether 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 pin and screw inserter fractured while driving screw into femur through a/p sizer.Attempts to obtain additional information have been made; however, no more information is available at this time.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.Visual examination of the returned product identified signs of repeated use and the tip hex feature was found to be fractured.All pieces were not returned.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received 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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