Description of Event or Problem · 0
A COMPLAINT WAS RECEIVED BY IZI MEDICAL PRODUCTS LLC REGARDING A BCN3120 BLAZER:C VAS SYSTEM (CATALOG NO. BCN3120, LOT NO. FP261059, UDI: (B)(4), EXPIRATION DATE: 2028-05-11) FOLLOWING A VERTEBROPLASTY PROCEDURE. THE DEVICE'S INSTRUCTIONS FOR USE (IFU) EXPLICITLY DESIGNATE THE BCN3120 AS A SINGLE-USE DEVICE. BASED ON THE VERBAL INFORMATION REPORTED BY THE PHYSICIAN ON (B)(6) 2026, THE DEVICE WAS USED SEQUENTIALLY AT TWO VERTEBRAL LEVELS (L2 AND L4) DURING A SINGLE PROCEDURE. THE PHYSICIAN BLAZED PATHS FOR L2 AND L4 AND THEN PROCEEDED WITH CEMENT INJECTION FOR BOTH L2 AND L4. THE PHYSICIAN COMPLETED CEMENT INJECTION AT THE L2 VERTEBRAE. WITH BONE CEMENT ALREADY PRESENT IN THE CANNULA, THE PHYSICIAN RETRACTED THE NITINOL WIRE AND RETRIEVED THE DEVICE FROM THE L2 VERTEBRAE BEFORE MOVING TO INJECT CEMENT AT THE L4 VERTEBRAE. THE REPORTED MALFUNCTION OCCURRED DURING CEMENT INJECTION AT THE SECOND LEVEL (L4), AT WHICH POINT THE DEVICE HAD BEEN USED OUTSIDE OF THE LABELED USE OF A SINGLE-USE DEVICE. ACCORDING TO THE PHYSICIAN, THE PHYSICIAN ADVANCED THE NITINOL WIRE FORWARD TO INJECT CEMENT INTO THE L4 VERTEBRAE AND COULD NOT RETRACT THE NITINOL WIRE BACK. THE PHYSICIAN RETAINED THE ABILITY TO ADVANCE THE NITINOL WIRE HOOK DISTALLY BUT WAS UNABLE TO RETRACT IT PROXIMALLY. USING IMAGING, THE PHYSICIAN CONFIRMED THAT A PORTION OF THE NITINOL WIRE SEGMENT WAS BROKEN. THE PHYSICIAN ATTEMPTED NITINOL WIRE RETRIEVAL USING A HEMOSTAT, FOLLOWED BY CONTROLLED TRACTION USING PLIERS ON THE ROD DURING PULLBACK. A NITINOL WIRE SEGMENT ESTIMATED AT APPROXIMATELY 1.1 CM IS BELIEVED TO HAVE REMAINED IN THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED BY THE PHYSICIAN. BASED ON BIOCOMPATIBILITY REVIEW OF THE DEVICE MATERIAL, THERE IS MINIMAL RISK TO THE PATIENT. PRELIMINARY REVIEW HAS NOT IDENTIFIED A MANUFACTURING NON-CONFORMANCE WHILE FULL INVESTIGATION IS ONGOING. THE FAILURE MODE IS CONSISTENT WITH MECHANICAL STRESS BEYOND THE DEVICE'S INTENDED SINGLE-USE DESIGN PARAMETERS. SUCCESSFUL PERFORMANCE AT L2 SUPPORTS THE CONCLUSION THAT THE DEVICE FUNCTIONED AS INTENDED WITHIN ITS LABELED USE CONDITIONS.