AC TIGHTROPE REPAIR KIT, TITANIUM

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 22ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-2257, AC TIGHTROPE¿ REPAIR KIT, TITANIUM, THE PATIENT EXPERIENCED ABNORMAL SOUNDS AND PAIN IN THE LEFT SHOULDER AFTER THE SURGERY. THIS WAS DETECTED DURING A MICROPLATE INTERNAL FIXATION SURGERY FOR LEFT SHOULDER-SCAPULA DISLOCATION UNDER ANESTHESIA ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED BY DOING A REVISION PROCEDURE ON (B)(6) 2025 FOR LEFT ACROMIOCLAVICULAR JOINT DISLOCATION OPEN REDUCTION WITH HOOK PLATE INTERNAL FIXATION, FOLLOWED BY INTRAVENOUS INFUSION FOR REDUCING SWELLING, RELIEVING PAIN AND PROVIDING SYMPTOMATIC TREATMENT. ADDITIONAL INFORMATION: 1. THE OPERATION ON (B)(6) 2025 WENT SMOOTHLY AND THE PATIENT WAS SAFELY RETURNED TO THE WARD. POSTOPERATIVELY, SYMPTOMATIC TREATMENT WAS PROVIDED, AND DRESSINGS WERE CHANGED ON TIME. 2. AT AROUND 21:00 ON (B)(6) 2025, THE PATIENT SUDDENLY EXPERIENCED ABNORMAL SOUNDS AND PAIN IN THE LEFT SHOULDER. A RE-EXAMINATION OF THE LEFT SHOULDER X-RAY ON (B)(6) 2025 AT 22:10 SHOWED THAT THE LEFT SHOULDER-SCAPULA JOINT WAS SEMI-DISLOCATED. COMPARING WITH THE POSTOPERATIVE STATE (10:17:14 ON (B)(6) 2025), THE JOINT SPACE HAD WIDENED TOO. 3. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2025.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D6A, G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, WHICH MAY INCLUDE IMAGES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX WAS ABLE TO DETERMINE THE MOST LIKELY CAUSE OF THE REPORTED ISSUE. THE FAILURE APPEARS TO BE PATIENT-SPECIFIC, POTENTIALLY RESULTING FROM FOREIGN BODY SENSITIVITY AND/OR NON-COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS DURING THE HEALING PERIOD. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.