Catalog Number 00133602800 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign: germany.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.H3 other text : see h10 narrative.
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Event Description
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It was reported that during kit inspection, the plastic impactor tip on the femoral impactor instrument was found to be fractured.There was no patient involvement and no adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
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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 repeated use with nicks, gouges, dings, and tool marks.The pad was identified as fractured.Additional testing of the fracture identified the fracture was potentially due to overloading, possibly exacerbated by embrittlement of the polymer after prolonged use.This complaint has been confirmed by product evaluation.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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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Event Description
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No further event information available at time of this report.
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Search Alerts/Recalls
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