K-LESS T-ROPE W/DRV, SYN REPR, 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 9/25/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL AN ISSUE INVOLVING THE AR-8925T SYNDESMOSIS TIGHTROPE XP. AFTER INSERTING THE INCLUDED GUIDE PIN INTO THE CLAVICLE BONE, THE SURGEON ATTEMPTED TO CREATE A BONE HOLE USING THE HOLLOW DRILL. HOWEVER, THE DRILL WAS UNABLE TO PENETRATE THE BONE. THE SURGEON COMMENTED THAT IT FELT AS THOUGH THE DRILL HAD CONTACTED THE GUIDE PIN AND STOPPED. UPON CONTINUING THE ATTEMPT TO DRILL, THE GUIDE PIN BROKE. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED WITHOUT COMPLICATION. THE SURGEON THEN USED AN ALTERNATIVE K-WIRE, BUT THE DRILL STILL FAILED TO ENTER THE BONE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING ANOTHER AR-8925T SYNDESMOSIS TIGHTROPE XP DEVICE. THERE WAS NO SIGNIFICANT SURGICAL DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE OBSERVED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE DAMAGE OBSERVED ON THE CUTTING BLADES OF THE RETURNED DRILL. ONE UNPACKAGED AR-8925T BATCH 15440384 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE, SUCH AS NICKS, TO THE CUTTING FLUTES OF THE RECEIVED DRILL. A FUNCTIONAL TEST WAS PERFORMED BY CONNECTING THE DRILL TO A HANDPIECE WITHOUT ISSUES. THE OVERALL LENGTH WAS MEASURED ACCORDING TO DRAWING C3529 AT REVISION 27. COMPONENT C3529-10 AT REVISION 12. OAL: 5.50 ± .03 INCHES. RESULT: 5.50 INCHES. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE BROKEN PIECE WAS THE GUIDE PIN. HOWEVER, THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION (REFER TO THE EMAIL). THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING IMPROPER SURGICAL TECHNIQUE. DIRECTIONS FOR USE DFU-0147-EO REVISION 5 TIGHTROPE DEVICES: G. PRECAUTIONS. 3. SURGEONS ARE ADVISED TO REVIEW THE PRODUCT-SPECIFIC SURGICAL TECHNIQUE PRIOR TO PERFORMING ANY SURGERY. ARTHREX PROVIDES DETAILED SURGICAL TECHNIQUES IN PRINT, VIDEO, AND ELECTRONIC FORMATS. THE ARTHREX WEBSITE ALSO PROVIDES DETAILED SURGICAL TECHNIQUE INFORMATION AND DEMONSTRATIONS. OR CONTACT YOUR ARTHREX REPRESENTATIVE FOR AN ONSITE DEMONSTRATION.