PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

DHR REVIEW: A REVIEW OF MANUFACTURING RECORDS WAS COMPLETED, AND FOUND THAT THE PRODUCT WAS IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. AFTER RETURNED COMPLAINT PRODUCT WAS RECEIVED AN EVALUATED, THESE RECORDS WERE REVIEWED ONCE MORE, PAYING SPECIAL ATTENTION TO THE BONDING OPERATION BETWEEN THE LIGHT FIBER AND DEPTH STOP, AND RE-CONFIRMED THAT ALL STEPS WERE FOUND TO BE PERFORMED PER THE MANUFACTURING INSTRUCTIONS AND IN SPECIFICATION. RETURNED PRODUCT EVALUATION: THE COMPLAINT DEVICE WAS RETURNED AND EVALUATED ON (B)(6) 2022. THIS EVALUATION FOUND THAT THE BLUE CAP WAS SECURELY ATTACHED TO THE Y-CONNECTOR, AND ABLE TO BE UNSCREWED AND RE-SCREWED ON, RENDERING THAT REPORTED DEVICE PROBLEM UNVERIFIED. HOWEVER, FURTHER EVALUATION FOUND THAT THE LIGHT FIBER WAS NOT SECURED WITHIN THE DEPTH STOP COMPONENT, AND COULD BE MOVED BACK AND FORTH, AS REPORTED IN THE COMPLAINT. FURTHER PRODUCT EVALUATION OF THE DEPTH STOP ONCE REMOVED FROM THE DEVICE, UNDER MAGNIFICATION, FOUND THAT A SMALL AMOUNT OF ADHESIVE WAS VISIBLE INSIDE THE DEPTH STOP ID, AND NO ADHESIVE WAS VISIBLE ON THE OUTER EDGES OF THE DEPTH STOP. THE DEPTH STOP APPEARANCE FROM THE COMPLAINT DEVICE WAS COMPARED TO THAT OF TWO DEPTH STOPS WHICH WERE REMOVED FROM TWO IN-SPECIFICATION LIGHT FIBER ASSEMBLIES. THE TWO DEPTH STOPS REMOVED FROM THE IN-SPECIFICATION LIGHT FIBER ASSEMBLIES HAD A RING OF GLUE AROUND THE EDGE OF THE DEPTH STOP ID VISIBLE, WHILE THE DEPTH STOP FROM THE COMPLAINT HAS NO GLUE VISIBLE ON THE EDGE OF THE DEPTH STOP ID. THERE IS ONLY A SMALL AMOUNT OF ADHESIVE VISIBLE INSIDE THE ID. THE COMPLAINT DEPTH STOP HAS LESS ADHESIVE ON IT AFTER BEING REMOVED FROM THE LIGHT FIBER THAN THE TWO OTHER DEPTH STOPS EXAMINED, AND THERE IS NO VISIBLE ADHESIVE ON THE LIGHT FIBER. SEE ATTACHMENT B FOR THE DETAILS OF THE RETURNED PRODUCT EVALUATION. ROOT CAUSE INVESTIGATION: THE POTENTIAL CAUSES OF THE LIGHT FIBER NOT BEING ADHERED TO THE DEPTH STOP WERE REVIEWED, THEN EACH POTENTIAL CAUSE WAS INVESTIGATED AND ELIMINATED IF POSSIBLE. THE MANUFACTURING PROCEDURE REVISION AT THE TIME OF MANUFACTURE WAS REVIEWED AND FOUND THAT THERE ARE CLEAR INSTRUCTIONS ON HOW MUCH ADHESIVE TO APPLY TO BOND THE DEPTH STOP, AND HOW TO CURE THE ADHESIVE. HOWEVER, IT WAS NOTED DURING THE RETURNED PRODUCT EVALUATION THAT THE DEPTH STOP HAD LESS VISIBLE ADHESIVE ON THE ID WHEN COMPARED TO OTHER LIGHT FIBER ASSEMBLY EXAMPLES. THE TRAINING RECORD OF THE OPERATOR WHO MANUFACTURED THE LIGHT PIPE WAS REVIEWED, AND FOUND THAT THE OPERATOR WAS TRAINED TO THE MANUFACTURING INSTRUCTION PRIOR TO THE DATE OF PERFORMING THE OPERATION. THE DHR WAS REVIEWED AND FOUND THAT THE ADHESIVE USED WAS THE CORRECT MATERIAL, AND IT WAS WITHIN THE EXPIRATION DATE. THE DHR REVIEW FOUND THAT THE GLUING STEP WAS PERFORMED USING THE GLUE DISPENSER. THE DHR REVIEW ALSO SHOWED THE DEPTH STOP TENSILE TEST WAS PERFORMED AND THE CORRECT LIGHT CURING WAS PERFORMED. DEVICE USE: IT IS VERY UNLIKELY THAT THE DEVICE WAS MISHANDLED BY THE USER IN SUCH A WAY THAT THE GLUE BONE WOULD BREAK, BECAUSE WHEN THE USER DISCOVERED THE LIGHT FIBER WAS LOOSE, THEY WERE PREPPING THE IMPLANT, WHICH INVOLVES LEAVING MOST OF THE LIGHT FIBER ON THE BACKER CARD, AND IT WOULD BE UNLIKELY ANY SIGNIFICANT FORCES WOULD BE PLACED ON THE LIGHT FIBER WHICH MIGHT BREAK THE GLUE BOND. AS ALL OTHER POTENTIAL ROOT CAUSES WERE ELIMINATED, AND DURING THE RETURNED PRODUCT EVALUATION THE AMOUNT OF ADHESIVE REMAINING ON THE DEPTH STOP WAS OBSERVED TO BE LESS THAN OTHER DEPTH STOPS AFTER GLUING, IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE USED DURING MANUFACTURING, A HUMAN ERROR REFLECTIVE OF THE MANUAL NATURE OF THIS PROCESS STEP. COMPLAINTS IN THE PREVIOUS 12 MONTHS (B)(6) 2021- (B)(6) 2022) WERE REVIEWED FOR OTHER INSTANCES OF LOT 410243 AND NO OTHER COMPLAINTS IN THIS LOT WERE IDENTIFIED. ADDITIONALLY, THERE WERE NO OTHER INSTANCES OF COMPLAINTS FOR THE FAILURE MODE OF LIGHT FIBER NOT SECURED IN DEPTH STOP WITH THIS 12 MONTH PERIOD. FURTHER COMPLAINT REVIEW FOUND THAT THERE WERE NO OTHER INSTANCES OF COMPLAINTS FOR THIS FAILURE MODE SINCE THE PRODUCT WAS INTRODUCED TO THE MARKET IN 2009. THIS INVESTIGATION CONFIRMED THAT THERE HAVE BEEN SEVERAL MANUFACTURING IMPROVEMENTS TO THE DEPTH STOP BONDING PROCESS SINCE THE LIGHT FIBER INVOLVED IN THIS COMPLAINT WAS MANUFACTURED IN JANUARY 2021. THE PROCESS IMPROVEMENTS MADE INCLUDE THE VALIDATION AND IMPLEMENTATION OF A NEW FIXTURE TO ALIGN THE DEPTH STOP, ADDING A DEDICATED DEPTH STOP MEASUREMENT SCALE, AND ADDING ADDITIONAL OPEN AIR CURING TO THE DEPTH STOP BOND IN ADDITION TO THE INITIAL CURING STEP. REVIEW OF IFU / POTENTIAL USER ERROR THE INSTRUCTIONS FOR USE, 900356 SPECIFY TO DISCARD AND TO NOT USE OPENED OR DAMAGED PACKAGES. IN THIS SITUATION THE DEFECT WOULD BE EASILY IDENTIFIABLE TO THE USER DURING IMPLANT PREPPING, AS IT WAS IN THIS SITUATION, AND DISCARDED DUE TO THE OBSERVED DAMAGE. THERE IS THE POTENTIAL THAT USER ERROR THROUGH MISHANDLING MAY HAVE BROKEN THE GLUE JOINT IN THE DEPTH STOP, AS THE SURGICAL TECHNIQUE GUIDES SPECIFY TO NOT PULL OR STRETCH THE LIGHT FIBER. HOWEVER, IT IS UNLIKELY THAT USER ERROR BY MISHANDLING CAUSED THIS FAILURE BECAUSE THE FAILURE WAS OBSERVED WHILE THE USER WAS STARTING TO PREPARE THE BALLOON, WHICH INVOLVES LEAVING THE MAJORITY OF THE LIGHT FIBER ON THE BACKER CARD WHILE HANDLING THE BALLOON CATHETER, SO IT WOULD BE UNLIKELY THAT THE LIGHT FIBER WOULD EXPERIENCE A SIGNIFICANT FORCE THAT MAY HAVE BROKEN THE ADHESIVE BOND. CONCLUSION THE MOST LIKELY ROOT CAUSE OF THE LIGHT FIBER NOT BEING ADHERED TO THE DEPTH STOP AND ABLE TO MOVE WITHIN THE CATHETER ASSEMBLY IS DUE TO INSUFFICIENT AMOUNT OF ADHESIVE USED DURING THE DEPTH STOP BONDING STEP, DUE TO HUMAN ERROR.

Description of Event or Problem

THIS MDR REPORT IS BASED ON THE RECLASSIFICATION OF A PREVIOUSLY REVIEWED COMPLAINT. DURING ROUTINE DEVICE PREPARATION OF AN ILLUMINOSS IMPLANT, A USER IDENTIFIED THAT THE LIGHT FIBER OF THE DEVICE WAS ABLE TO MOVE WITHIN THE BALLOON CATHETER AND THE BLUE SCREW CONNECTOR WAS LOOSE AND COULDN'T BE TIGHTENED. THIS DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.