This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned tasp to verify item and lot combination and reviewed manufacturing date as returned tasp exhibits signs of repeated use (nicked & gouged).The tasp was returned fractured at the post and all the pieces were returned.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause was unable to be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in a zrm, which 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.
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