SYNDESMOSIS TIGHTROPE PRO IMPLANT, TI

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 11-JUN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9925T SYNDESMOSIS TIGHTROPE PRO IMPLANT EXPERIENCED AN ISSUE DURING USE. THE IMPLANT WAS INITIALLY ADVANCED ACROSS THE JOINT, AND THE BLACK BUTTON WAS PULLED BACK. X-RAY CONFIRMED THE BUTTON WAS POSITIONED ACROSS. ADDITIONAL MANIPULATION WAS PERFORMED BY APPLYING PRESSURE ON THE MEDIAL SIDE WHILE SLIGHTLY RETRACTING THE HANDLE. A SUBSEQUENT X-RAY SHOWED THE BUTTON HAD MIGRATED INTO THE TIBIA. TO AVOID THE RISK OF THE BUTTON FLIPPING WITHIN THE TIBIA, THE SURGEON ELECTED TO REMOVE THE IMPLANT COMPLETELY. THE ISSUE OCCURRED DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE WITH SYNDESMOTIC FIXATION ON 10-JUN-2026, WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-JUN-2026: THE REPLACEMENT IMPLANT USED TO COMPLETE THE PROCEDURE WAS ANOTHER AR-9925T. THE SURGERY WAS NOT DELAYED, AS A NEW IMPLANT WAS OPENED AND SUCCESSFULLY IMPLANTED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PORTION OF THE ORIGINAL DEVICE WAS RETAINED IN THE PATIENT. FOLLOWING REMOVAL, THE IMPLANT WAS VISUALLY INSPECTED, AND NO DAMAGE, DEFORMATION, OR ABNORMALITIES WERE OBSERVED. THE PROCEDURE WAS COMPLETED USING THE STANDARD FIXATION TECHNIQUE FOR THE AR-9925T. NO ADDITIONAL BONE PREPARATION OR DRILLING WAS REQUIRED AFTER REMOVAL OF THE INITIAL IMPLANT. A CANNULATED DRILL BIT FROM THE ASSOCIATED KIT WAS USED TO PREPARE THE BONE SOCKET PRIOR TO INSERTION. THE PATIENT¿S BONE QUALITY WAS REPORTED AS GOOD. NO ADVERSE PATIENT EFFECTS WERE NOTED DURING OR AFTER THE PROCEDURE RELATED TO THIS EVENT.