It was reported that the patient experienced hardware removal of a synthes tibial nail.During the procedure a piece of the nail broke off and became stuck in a competitor's extractor.The original procedure was performed approximately 15 years ago and the nail was not locked distally or proximally.The patient experienced knee pain and the nail was subsequently discovered to have migrated into the knee joint.Approximately 80% of the nail was left in the tibia.No surgical delays were reported and the procedure was successfully completed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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