Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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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 tasps were returned fractured on a worn instrument claim form.Fracture was found after cleaning, before reassembling the tray.All pieces have been returned.
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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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Manufacturer Narrative
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This complaint was confirmed by review of returned device.Visual evaluation of the returned product exhibits signs of repeated use (nicked or gouged) and anterior section of the post feature has fractured off.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in a zrm, which identified 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.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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Search Alerts/Recalls
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