PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

THE DOCTOR SCREWED THE EMPTY SYRINGE ONTO THE CATHETER AND BEGAN THE PREPARATION. WHEN THE CATHETER COULDN'T BE COMPLETELY VENTED, HE PREFILLED THE CATHETER WITH MONOMER. EVEN AFTER THIS PROCESS, THE REMAINING AIR COULDN'T BE REMOVED. THEY USED A NEW IMPLANT, WHICH WORKED WITHOUT ANY PROBLEMS.

Additional Manufacturer Narrative

A RETURN PRODUCT KIT WAS SHIPPED TO GERMANY TO OBTAIN THE DEVICE FOR INVESTIGATION. THE RETURNED DEVICE WAS SHIPPED FROM GERMANY ON SEPTEMBER 1, 2025 TO THE US FOR DECONTAMINATION. THE RETURNED PRODUCT WAS HELD IN CUSTOMS IN THE US UNTIL SEPTEMBER 26, 2025. THE DEVICE WAS THEN SENT FOR DECONTAMINATION AND PHOTO DOCUMENTATION. THE RETURNED IMPLANT WAS EVALUATED AT ILLUMINOSS ON AFTER DECONTAMINATION AND PHOTO DOCUMENTATION WAS COMPLETED. THE LOCATION OF THE LEAK WAS ABLE TO BE DETERMINED THROUGH VISUAL INSPECTION AND LEAK TESTING. THE VISUAL INSPECTION SHOWED A SMALL AMOUNT OF PARTIALLY CURED MONOMER PRESENT ON THE BOND BETWEEN THE PROXIMAL PORTION OF THE BALLOON AND THE FLOW TUBE, WHICH WOULD NOT BE PRESENT IN NORMAL USE OF THE DEVICE WITH NO LEAK. THE BALLOON CATHETER ASSEMBLY WAS THEN INFLATED AND PRESSURIZED WITH AIR AND SUBMERGED IN WATER WHERE BUBBLES COULD BE SEEN ESCAPING THROUGH THE PROXIMAL BALLOON-FLOW TUBE JOINT. IT WAS ALSO OBSERVED THAT IN A NON-LEAKING IMPLANT, A SMALL AMOUNT OF ADHESIVE IS VISIBLE AROUND THE PROXIMAL PORTION OF THE BALLOON AND THE FLOW TUBE WHERE THE BOND IS FORMED, BUT IN THIS RETURNED PRODUCT NONE WAS VISIBLE. THIS SUGGESTS THAT AN INSUFFICIENT AMOUNT OF ADHESIVE MAY HAVE BEEN APPLIED TO THIS JOINT DURING THE MANUFACTURING PROCESS. DHR REVIEW: THE DHR OF THE IMPLANT WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. PER THE DHR, ALL CATHETER ASSEMBLIES HAD THE FLOW TUBE BONDED TO THE BALLOON. ALL BALLOON CATHETER ASSEMBLIES PASSED THEIR LEAK TESTING PRIOR TO FINAL RELEASE. THE ADHESIVE USED WAS WITHIN ITS EXPIRATION DATE. THERE IS NO INDICATION IN THE MANUFACTURING DHR THAT A MANUFACTURING NONCONFORMITY OCCURRED. THE MANUFACTURING PROCESS INCLUDES 100% LEAK TESTING OF THE BALLOON CATHETER ASSEMBLIES PRIOR TO RELEASE. ALL THE BALLOON CATHETER ASSEMBLIES IN THIS LOT PASSED THEIR LEAK TESTING. THIS INDICATES THAT AT THE TIME OF MANUFACTURE AND RELEASE THE ASSEMBLY DID NOT HAVE A LEAK, BUT THE BOND MAY HAVE BEEN INSUFFICIENTLY FORMED AND WEAK. THEN WHEN THE CATHETER ASSEMBLY WAS REMOVED FROM THE PACKAGING BY THE USER AND PRIMED, THIS SMALL AMOUNT OF HANDLING MAY HAVE DAMAGED THE WEAK BOND, RESULTING IN A LEAK. CONCLUSION: THE CAUSE OF THE LEAK IN THE BALLOON CATHETER ASSEMBLY WAS DUE TO AN INSUFFICIENT BOND BETWEEN THE PROXIMAL END OF THE BALLOON WITH THE FLOW TUBE CATHETER. AS THERE WAS NO VISIBLE ADHESIVE RING AT THIS BOND LOCATION, WHICH IS TYPICAL IN NON-LEAKING IMPLANTS, THE MOST LIKELY CAUSE OF THE LEAK WAS AN INSUFFICIENT AMOUNT OF ADHESIVE APPLIED DURING THIS BONDING OPERATION.

Additional Manufacturer Narrative

THIS INVESTIGATION INTO THIS EVENT IS CURRENTLY ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE DOCTOR SCREWED THE EMPTY SYRINGE ONTO THE CATHETER AND BEGAN THE PREPARATION. WHEN THE CATHETER COULDN'T BE COMPLETELY VENTED, HE PREFILLED THE CATHETER WITH MONOMER. EVEN AFTER THIS PROCESS, THE REMAINING AIR COULDN'T BE REMOVED. THEY USED A NEW IMPLANT, WHICH WORKED WITHOUT ANY PROBLEMS.