This device is not cleared in the us, but is similar to k111301.Device evaluation: visual investigation reveals that the inner hexes on four of the blockers were stripped.Functional investigation using mating parts showed that the blockers with damaged threads were non-functional because they could not fully engage the blocker holder.Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during tightening.Dhr review and related actions: per the dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3003853072-2021-00005 thru 3003853072-2021-00008.
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