K-LESS T-ROPE W/DRV, SYN REPR, TI

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION AVAILABLE ¿ INCLUDING ANY RETURNED DEVICE (IF PROVIDED), PHOTOGRAPHS, VIDEOS, THE EVENT DESCRIPTION, AND FIELD FEEDBACK. ARTHREX HAS DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED ISSUE IS IMPROPER SURGICAL TECHNIQUE DURING DEVICE INSERTION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE INCLUDES: IMPROPER BONE PREPARATION, RESULTING IN INADEQUATE OR MIS-SHAPED SEATING OF THE IMPLANT. MISALIGNED INSERTION, CAUSING THE IMPLANT TO ENGAGE THE BONE AT AN INCORRECT ANGLE OR TRAJECTORY. PRYING OR LEVERAGING THE DEVICE DURING INSERTION CAN INTRODUCE UNINTENDED MECHANICAL STRESS AND LEAD TO DAMAGE, DEFORMATION, OR COMPROMISED ENGAGEMENT.

Description of Event or Problem

ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE BUTTON OF AN AR-8925T SYNDESMOSIS TIGHTROPE XP WOULD NOT PROPERLY SIT ON THE END OF THE INSERTER. UPON REMOVAL FROM THE PACKAGING, THE DEVICE REPEATEDLY FELL OFF AND FAILED TO REMAIN ATTACHED. THE SURGEON ATTEMPTED TO USE THE DEVICE, BUT THE BUTTON WOULD NOT FLIP AS INTENDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 09/26/2025.

Additional Manufacturer Narrative

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