Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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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Event Description
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It was reported that a fractured instrument was received via the worn instrument return program.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use and the locking feature has fractured.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in previous investigation.It identified that the common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface.A definitive root cause cannot be determined.If any further information is found 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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