It was reported that the patient had under went left total knee arthroplasty.During patella resection, the blade hit the cutting guide & broke the tip of the blade.This added approximately five minutes to the cases, finding the blade & opening a new blade.All pieces were found.This account has had multiple reports of the blades breaking during total procedures.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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