PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. FLEXIBLE REAMER/BURR BREAK AT THE TIP WHILE BENDING AROUND THE PELVIS. SURGERY WAS NOT HINDERED. THE USER WAS ABLE TO PLACE THE ILLUMINOSS IMPLANT AND COMPLETE THE SURGERY. NO PATIENT HARM.

Additional Manufacturer Narrative

THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. FOLLOWUP INFORMATION PROVIDED BY THE USER: DURING CANAL PREPARATION FOR A METASTATIC PELVIS CASE, A FRONT CUTTING BURR AND A FLEXIBLE REAMER BROKE WHILE BENDING AROUND THE PELVIS. THE INSTRUMENTS WERE USED WITH THE BALL TIPPED GUIDEWIRE, AND ALL PIECES OF THE INSTRUMENTS WERE ABLE TO BE REMOVED. NO OTHER TOOLS WERE REQUIRED TO PREPARE THE CANAL AND THERE WAS NO SIGNIFICANT TIME DELAY. THE IMPLANT PROCEDURE WAS PERFORMED AS PLANNED. RECORDS REVIEW: PRODUCT IDENTIFICATION INFORMATION WAS NOT MADE AVAILABLE TO THE MANUFACTURER. REQUESTS TO IDENTIFY DEVICE LOT NUMBER WERE UNSUCCESSFUL. THEREFORE NO REVIEW OF MANUFACTURING RECORDS COULD BE PERFORMED FOR THIS COMPLAINT. RETURNED PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE FIRM FOR EVALUATION, AS IT WAS DISPOSED OF IN THE OR. ALTHOUGH THE PRODUCT WAS NOT RETURNED FOR EVALUATION, AN IMAGE OF THE TIP OF A BROKEN INSTRUMENT WAS PROVIDED. THE IMAGE SHOWS THE BURR OR REAMER BROKEN APPROXIMATELY AN INCH FROM THE CUTTING TIP ALONG THE LASER CUT PATTERN. THE BREAK APPEARS TO BE CLEAN ALONG THE LASER CUT PATTERN. THE BREAK PATTERN EXPERIENCED IN THIS CASE IS CONSISTENT WITH OVER-TORQUING OF THE DEVICE DURING USE. THE FIRM NOTED THAT THE USER REPORTED THAT THE INSTRUMENTS WERE BENT SIGNIFICANTLY DURING USE, WHICH INCREASES THE TORQUE STRESS ON THE DEVICE, AND COULD RESULT IN THE REPORTED BREAKS. CONCLUSION: EXISTING EVIDENCE SUPPORTS THAT OVER-TORQUING OF THE DEVICE IS A PROBABLE CAUSE OF THIS EVENT, ALTHOUGH THIS CANNOT BE DEFINITELY PROVEN WITH THE EVIDENCE AVAILABLE TO THE FIRM AT THIS TIME.