It was reported that the black impactor tip for an itotal identity cr knee broke in half during use on the tibial tray.The surgeon utilized the femoral impactor tip to impact the tibia baseplate upon cementing.This issue did not cause any delays in surgery and the procedure was completed successfully.The broken part was returned for an engineering review.After further investigation, it appears that the tibial impactor tip had been previously misused for quite some time, this is most likely what caused the failure.The impactor tip had visible damage marks on both sides of the mating interface.This area of the part should not be contacted or impacted during the procedure.It appears that instead of pulling the impactor tip off of the adapter that it mates with, a mallet or an equivalent blunt object was used to forcibly remove it.The device is not intended to be used in this manner and most likely, the forceful blows on the sides of the impactor tip, weakened the part causing it to break when being used to impact the tibial tray.
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