BOJIN MICRO TYPE MEDICAL ELECTRIC SAW & DRILL

Description of Event or Problem

DESCRIPTION OF EVENT: IT WAS REPORTED DURING TOTAL KNEE ARTHROPLASTY THAT THE SAW WAS DEFECTIVE AND COULD NOT BE USED NORMALLY, WHICH DELAYED THE SURGERY BY ONE HOUR AND PREVENTED IT FROM PROCEEDING AS PLANNED. NO PATIENT IMPACT REPORTED. THE INSTRUMENT SUPPLIER WAS IMMEDIATELY CONTACTED TO PROVIDE A REPLACEMENT SAW, WHICH WAS THEN SENT TO THE STERILIZATION SUPPLY ROOM FOR DISINFECTION. THE SURGERY RESUMED ONLY AFTER THE INSTRUMENT WAS DISINFECTED, RESULTING IN A ONE-HOUR DELAY. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".