Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported that the instrument was found fractured in sterile processing during cleaning after the case.There was no patient involvement.
|
|
Manufacturer Narrative
|
Visual inspection of the returned tasp exhibits signs of repeated use (nicked & gouged) and its fractured at the post.Dhr was reviewed and no discrepancies relevant 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.The zrm 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.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|