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 (B)(6) 2026, A PATIENT REPORTED VIA EMAIL THAT THE PATIENT UNDERWENT AN ANKLE REPAIR PROCEDURE IN (B)(6) 2025 THAT INCLUDED THE IMPLANTATION OF AN AR-8925T SYNDESMOSIS TIGHTROPE XP, TITANIUM. THE PATIENT STATED THEY APPEAR TO BE EXPERIENCING AN ALLERGIC REACTION TO THE IMPLANTED HARDWARE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-MAR-2026: THE PATIENT UNDERWENT REPAIR OF A FRACTURED FIBULA ON (B)(6) 2025 DUE TO A FIBULA FRACTURE OCCURRING IN TWO LOCATIONS. ON (B)(6) 2025, SHORTLY AFTER THE EFFECTS OF ANESTHESIA WORE OFF, THE PATIENT REPORTED AN INABILITY TO TOLERATE WEARING A BOOT, GAUZE, BRACE, ACE BANDAGE, OR COMPRESSION SOCK DUE TO SIGNIFICANT PAIN. THE REPORTED SIGNS AND SYMPTOMS INCLUDED "EXTREME PAIN AND BURNING" AT THE INCISION SITE, PARTICULARLY WHEN ANY PRESSURE WAS APPLIED OR WHEN BANDAGES, CLOTHING, OR BEDDING MADE CONTACT WITH THE AREA. THE REACTION HAS REMAINED LOCALIZED TO THE SURGICAL SITE. SYMPTOMS HAVE GRADUALLY IMPROVED WITH PHYSICAL THERAPY AND THE USE OF IBUPROFEN. THE ISSUES HAVE IMPACTED THE PATIENT¿S DAILY ACTIVITIES, INCLUDING IMPAIRED SLEEP DUE TO BURNING AT THE INCISION SITE, INABILITY TO WEAR A SOCK OR SHOE ON THE AFFECTED FOOT, AND INABILITY TO WORK. CURRENT TREATMENT INCLUDES PHYSICAL THERAPY AND IBUPROFEN. NO ADDITIONAL SURGERY HAS BEEN SCHEDULED AT THIS TIME.