KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

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 (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2372BLO AC TIGHTROPE SUTURES BROKE AND THE TIGHTROPE CONSTRUCT FAILED 3 MONTHS POST OP. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT, ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. PER DFU-0377-EO, REVISION 2, SECTION E. WARNINGS: 7. ¿POSTOPERATIVELY AND UNTIL HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE AND BONE.¿