PRECICE® BONE TRANSPORT SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION REVEALED THAT A PRECICE BONE TRANSPORT NAIL MODEL BT10-80D320-7, LOT NUMBER 3083004AAA, WAS RETURNED TO GLOBUS MEDICAL FOR COMPLAINT INVESTIGATION. THE COMPLAINT REPORTED THAT THE DEVICE FAILED TO DISTRACT WHILE IN-SITU, AND WHEN REMOVED AND TESTED WITH AN ERC AND FAST DISTRACTOR, THE NAIL STILL WOULD NOT DISTRACT. UPON RECEIPT OF THE DEVICE, A VISUAL INSPECTION WAS CONDUCTED. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE SHORTEST DISTANCE MEASURED FROM THE DISTRACTION ROD TO THE CLOSEST DISTAL SCREW HOLE WAS MEASURED AT 156.83MM. THIS IS A SMALLER DISTANCE THAN ANY OF THE DISTANCES MEASURED AS A PART OF RELEASE TESTING FOR ALL 4 NAILS IN THE LOT. THIS SUGGESTS THAT THE DISTRACTION ROD WAS OVER RETRACTED AND POSSIBLY JAMMED. IN-HOUSE X-RAY WAS PERFORMED AND NOTED THAT THERE WAS A SMALL GAP BETWEEN ONE OF THE PLANET GEARS AND ITS SUN GEAR. THIS WOULD DISCONNECT THE GEAR TRAIN AND CAUSE THE DISTRACTION ROD TO NOT MOVE WHILE THE MAGNET IS SPINNING. FUNCTIONAL TESTING PER AT0075 WAS PERFORMED AND WAS UNSUCCESSFUL. DURING TESTING, THE DISTRACTION ROD WAS UNABLE TO DISTRACT AND DID NOT PRODUCE THE REQUIRED 180LBS OF FORCE, CONFIRMING THE COMPLAINT OF A FAILURE TO DISTRACT. SECTIONING THE DEVICE CONFIRMED THAT THE BROKEN GEAR WAS SHEARED OFF FROM EXCESS TORQUE. IN CONCLUSION, THE COMPLAINT FOR FAILURE TO DISTRACT WAS CONFIRMED DUE TO USER ERROR AS IT IS LIKELY THAT EXCESSIVE FORCE WAS APPLIED IN THE WRONG DIRECTION TO DAMAGE THE INTERNAL COMPONENTS PREVIOUSLY MENTIONED. SINCE THE NAIL WAS JAMMED, THE EXCESS TORQUE THAT WAS BEING APPLIED IN THE INCORRECT DIRECTION WAS APPLIED TO THE SUN GEAR EXPERIENCING THE HIGHEST AMOUNT OF TORQUE, THUS CAUSING IT TO SHEAR OFF FROM ITS PLANETS. A REVIEW OF THE DHR DOCUMENTS INDICATES THE DEVICE WAS MANUFACTURED BY THE SPECIFIED REQUIREMENT AT THE TIME AND MET ALL THE REQUIRED INSPECTIONS BEFORE SHIPMENT. THE ASSOCIATED RISK DOCUMENT WAS REVIEWED, AND THE FAILURE MODE, EFFECTS, AND HARMS POTENTIALLY RELATED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AND MITIGATED. FURTHERMORE, THE COMPLAINT RATE IS WITHIN THE ESTIMATED RATE IN THE RISK DOCUMENTATION ASSOCIATED WITH THIS PRODUCT. BASED ON THIS RISK ASSESSMENT, NO NEW OR ADDITIONAL RISK EVALUATION IS NECESSARY.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT ANKLE ARTHRODESIS, AND A BONE TRANSPORT FEMUR NAIL, PREVIOUSLY PLANNED BY THE SURGEON, WAS IMPLANTED. DURING POSTOPERATIVE FOLLOW-UP, IT WAS OBSERVED THAT THE IMPLANT WAS NOT FUNCTIONING. A NEW SURGERY WAS SCHEDULED FOR (B)(6) 2025. THE IMPLANT WAS CHECKED BOTH INSIDE AND OUTSIDE THE PATIENT USING A FAST DISTRACTOR AND WITH ERC (ELECTROMAGNETIC RESONANCE IMAGING), AND THE MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. THEREFORE, IT WAS DECIDED TO REPLACE IT WITH A NEW ONE, WHICH ULTIMATELY DID FUNCTION. THE DELAY IN REPORTING THE INCIDENT WAS DUE TO THE HOSPITAL FIRST DECONTAMINATING THE NAIL, AND THEN SEVERAL INTERNAL COMMUNICATION ERRORS (AN INTERNAL NON-CONFORMITY REPORT HAS BEEN FILED REGARDING THIS ISSUE, AND TRAINING WILL BE PROVIDED).

Additional Manufacturer Narrative

THE DEVICE HAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT ANKLE ARTHRODESIS, AND A BONE TRANSPORT FEMUR NAIL, PREVIOUSLY PLANNED BY THE SURGEON, WAS IMPLANTED. DURING POSTOPERATIVE FOLLOW-UP, IT WAS OBSERVED THAT THE IMPLANT WAS NOT FUNCTIONING. A NEW SURGERY WAS SCHEDULED FOR (B)(6) 2025. THE IMPLANT WAS CHECKED BOTH INSIDE AND OUTSIDE THE PATIENT USING A FAST DISTRACTOR AND WITH ERC (ELECTROMAGNETIC RESONANCE IMAGING), AND THE MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. THEREFORE, IT WAS DECIDED TO REPLACE IT WITH A NEW ONE, WHICH ULTIMATELY DID FUNCTION.