PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

AT THE TIME OF THE INITIAL MDR SUBMISSION FOR THIS EVENT, THE INVESTIGATION INTO THE CAUSE OF THIS EVENT WAS STILL UNDERWAY. THIS FOLLOWUP MDR IS SUBMITTED TO SUBMIT NEW INFORMATION, INCLUDING PRODUCT EVALUATION RESULTS OF RETURNED COMPLAINT DEVICE; THE INVESTIGATION FINDINGS CODES; INVESTIGATION CONCLUSION CODES; AND THIS MANUFACTURER'S NARRATIVE WITH THE FIRM'S ROOT CAUSE CONCLUSIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE USED IN THIS CASE WAS PERFORMED AND FOUND THAT THE DEVICE MET ITS FINAL RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND RELEASE. A REVIEW OF COMPLAINTS FOUND NO OTHER COMPLAINTS FOR THIS LOT NUMBER. RETURNED PRODUCT EVALUATION WAS ABLE TO VERIFY THE COMPLAINT, AND IDENTIFY THE PRESENCE OF A LARGE, CLEAN TEAR IN THE BALLOON, WHICH WAS THE CAUSE OF THE LEAK. THE PRESENCE OF THIS LARGE CLEAN TEAR IN THE BALLOON IS INDICATIVE OF THE BALLOON BEING CUT BY COMING INTO CONTACT WITH SOMETHING. FOLLOWUP INFORMATION WAS REQUESTED AND RECEIVED FROM THE DISTRIBUTOR. THE DISTRIBUTOR PRESENT DURING THIS CASE DESCRIBED THAT THE TYPICAL CANAL PREP STEPS WERE FOLLOWED: USING A PIN TO START THE ENTRY HOLE, THEN AN ENTRY DRILL TO FORM THE ENTRY HOLE, THEN A GUIDEWIRE DOWN THE CANAL, AND FINALLY REAMING OF THE CANAL. THE DISTRIBUTOR ALSO DESCRIBED THAT AS THE USER STARTED INFUSING MONOMER THE BALLOON WAS INFLATING AND HOLDING ITS SHAPE. UPON INFUSION OF THE BEGINNING OF THE 4TH VIAL OF MONOMER, THE USER SAID THEY HEARD AN AUDIBLE POPPING SOUND, AND SAW THE BALLOON DEFLATE UNDER X-RAY. THEN THE BALLOON WAS REMOVED, AND A HOLE IN THE BALLOON COULD BE SEEN. THE HUMERUS WAS WASHED OUT, AND ANOTHER IMPLANT WAS SUCCESSFULLY USED, AND THE PATIENT HAD A GOOD OUTCOME. THE DISTRIBUTOR DID NOT STATE THAT ANY INSTRUMENTS, OR FRACTURE REDUCTION ADJUSTMENTS WERE MADE DURING THE INFUSION PROCESS. THIS DESCRIPTION OF EVENTS INDICATES THAT THE BALLOON DID NOT HAVE A LEAK DURING THE INITIAL INFUSION OF MONOMER AS IT WAS INFLATING AND HOLDING ITS SHAPE. THIS SUGGESTS THAT AS THE BALLOON WAS REACHING ITS MAXIMUM SIZE (AS THE USER INFUSED THE 4TH OF 4 VIALS OF MONOMER) THE BALLOON BECAME PRESSED AGAINST SOMETHING IN CONTACT WITH THE BALLOON SURFACE, FOR INSTANCE A SHARP FRAGMENT OF BONE, AN INSTRUMENT, OR OTHER HARDWARE, AND WAS CUT. THE PRODUCT EVALUATION SUPPORTS THIS ANALYSIS, AS THE LARGE CLEAN TEAR IN THE BALLOON IS INDICATIVE OF THE BALLOON BEING CUT BY COMING INTO CONTACT WITH SOMETHING. CONCLUSION THE CAUSE OF THE BALLOON LEAK WAS A LARGE CLEAN TEAR IN THE BALLOON. A PROBABLE CAUSE FOR THIS TEAR IS THE BALLOON COMING INTO CONTACT WITH A SHARP FRAGMENT OF BONE, AN INSTRUMENT, OR OTHER HARDWARE AS IT WAS BEING INFUSED WITH MONOMER. THE TEAR OBSERVED IN THE PET SOFT WALL OF THE BALLOON THROUGH PRODUCT EVALUATION, PLUS THE TIMING OF THE OCCURRENCE OF THE TEAR (IN SITU), SUPPORT THE CONCLUSION THAT THE IMPLANT WAS INFLATING AGAINST A SHARP SURFACE OR OBJECT WAS TORN, CAUSING THE LEAK.

Additional Manufacturer Narrative

AT THE TIME OF THIS INITIAL MDR REPORT, THE INVESTIGATION INTO THE CAUSE OF THE EVENT IS STILL ONGOING. THE PRODUCT WAS ABLE TO BE RETURNED TO THE FIRM FOR DEVICE EVALUATION. DEVICE DECONTAMINATION WAS INITIATED ON 24 APRIL 2023. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE USED IN THIS CASE WAS PERFORMED AND FOUND THAT THE DEVICE MET ITS FINAL RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND RELEASE. A REVIEW OF COMPLAINTS FOUND NO OTHER COMPLAINTS FOR THIS LOT NUMBER. FOLLOWUP INFORMATION HAS BEEN REQUESTED OF THE USER. PRODUCT EVALUATION IS IN PROCESS OF BEING PERFORMED AT THIS TIME A FOLLOWUP MDR WILL BE SUBMITTED WHEN FURTHER INFORMATION IS KNOWN ABOUT THIS CASE.

Description of Event or Problem

A 71 YEAR-OLD MALE WAS BEING TREATED FOR AN IMPENDING PATHOLOGIC FRACTURE OF THE HUMERUS, USING AN ILLUMINOSS IMPLANT. THE USER WAS INFUSING THE ILLUMINOSS IMPLANT BALLOON FOR THIS PROCEDURE [SIZE 22/13X260] WITH MONOMER, WHEN THEY EXPERIENCED A LEAK. THE LEAK WAS EXPERIENCED UPON INFUSION OF THE 4TH SYRINGE OF MONOMER. THE BALLOON WAS REMOVED, AND A HOLE WAS FOUND IN THE BALLOON. ANOTHER ILLUMINOSS IMPLANT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE, AND THE PATIENT OUTCOME WAS GOOD.