Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that the device was fractured during sterilization process.Attempt for further information has been made, but 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 is fractured on medial side of post.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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