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Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3, H6.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED ON 12/4/2025: THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025, AND PER THE PATIENT, THE ARTHREX PRODUCT WAS EXPLANTED. HOWEVER, THE PATIENT DOES NOT HAVE THE PART NUMBERS FOR THE PRODUCT. THE PATIENT IS CURRENTLY IN A SLING AND HAS A NERVE BLOCKER IN PLACE, RESULTING IN NO PAIN.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D6B, G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD INFORMATION, ARTHREX CONCLUDED THE MOST LIKELY CAUSE. THE REPORTED FAILURE IS MOST LIKELY DUE TO A PATIENT-SPECIFIC EVENT, SUCH AS INSUFFICIENT BONE QUANTITY OR QUALITY, STRESS TO THE EXTREMITY FROM EXCESSIVE FORCES DURING GOLF / OTHER ACTIVITIES, OR INDIVIDUAL VARIATIONS IN HEALING. ACTIVITY RESTRICTIONS AFTER IMPLANTATION ARE PATIENT-SPECIFIC AND DEPEND ON THE ANATOMICAL SITE, FIXATION STABILITY, AND SURGEON PREFERENCE. GENERAL RECOMMENDATIONS INCLUDE FOLLOWING ALL POSTOPERATIVE INSTRUCTIONS PROVIDED BY THE TREATING PROFESSIONAL. POSTOPERATIVE MANAGEMENT IS ALSO PATIENT-SPECIFIC AND GUIDED BY THE PROFESSIONAL¿S ASSESSMENT. THE FIXATION SHOULD BE CONSIDERED TEMPORARY UNTIL HEALING IS COMPLETE, AND ALL PRESCRIBED ACTIVITY RESTRICTIONS SHOULD BE STRICTLY FOLLOWED AS DIRECTED BY THE PHYSICIAN. MINI TIGHTROPE (CMC JOINT, HAND/WRIST). REHABILITATION PROTOCOLS ARE TYPICALLY SHORTER COMPARED TO LRTI PROCEDURES. IMMOBILIZATION IS 3¿10 DAYS, WITH PARTIAL MOBILIZATION ALLOWED BETWEEN 2 AND 6 WEEKS, AND FULL ACTIVITY BY 12 WEEKS. DIRECTIONS FOR USE DFU-0147-EO REVISION 4 TIGHTROPE® DEVICES: C. CONTRAINDICATIONS 1. INSUFFICIENT QUANTITY OR QUALITY OF BONE. 6. CONDITIONS THAT TEND TO LIMIT THE PATIENT'S ABILITY OR WILLINGNESS TO RESTRICT ACTIVITIES OR FOLLOW DIRECTIONS DURING THE HEALING PERIOD. E. WARNINGS: 9. 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. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED ON 15-JAN-2026: MEDICAL RECORDS DOCUMENT THAT THE PATIENT UNDERWENT A RIGHT THUMB SUSPENSION ARTHROPLASTY ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST ANCHOR DID NOT HOLD AND A SECOND ANCHOR WAS REQUIRED TO OBTAIN FIXATION. SUBSEQUENT FOLLOW-UP VISITS IN (B)(6) 2025 NOTED ACCEPTABLE EARLY HEALING, BUT IMAGING ON (B)(6) 2025 DEMONSTRATED LOSS OF FIXATION WITH PROXIMAL MIGRATION OF THE THUMB METACARPAL, CONSISTENT WITH FAILURE OF THE SUSPENSIONPLASTY. THE PATIENT LATER UNDERWENT REVISION SURGERY ON (B)(6) 2025. INTRAOPERATIVELY, SUTURE FAILURE AND INSTABILITY OF THE PRIOR CONSTRUCT WERE OBSERVED, ALONG WITH RETAINED SUTURE LIMBS AND A RETAINED BONE ANCHOR THAT REQUIRED REMOVAL. THE REVISION PROCEDURE INCLUDED RECONSTRUCTION USING NEW IMPLANTS, WITH STABLE FIXATION ACHIEVED AND NO COMPLICATIONS REPORTED.

Description of Event or Problem

ON 11/07/2025, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT ON (B)(6) 2025, SURGERY WAS PERFORMED TO REMOVE THE RIGHT THUMB JOINT DUE TO PAIN FROM ARTHRITIS. ACCORDING TO THE PATIENT, THE ARTHREX TIGHTROPE SOLUTION WAS RECOMMENDED AND USED TO SECURE THE THUMB TO THE INDEX FINGER. THE PATIENT REPORTED THAT SINCE THE THUMB SURGERY, ALL POSTOPERATIVE INSTRUCTIONS WERE FOLLOWED, AND ACTIVITIES WERE LIMITED TO ALLOW SCAR TISSUE FORMATION AND ADAPTATION TO THE TIGHTROPE. A HAND CAST WAS WORN FOR APPROXIMATELY SIX WEEKS FOLLOWING SURGERY. IN LATE OCTOBER, LIGHT ACTIVITIES, SUCH AS GOLF, WERE RESUMED. THE PATIENT REPORTED THAT DURING ONE SWING IN LIGHT, ROUGH CONDITIONS, IMMEDIATE DISCOMFORT WAS FELT IN THE THUMB JOINT AREA. ACCORDING TO THE PATIENT, X-RAY IMAGES CONFIRMED THE TIGHTROPE HAD FAILED AND WAS REFERRED TO CONSULT WITH A RECONSTRUCTIVE HAND SURGEON. THE PATIENT WAS ADVISED TO WAIT SIX WEEKS TO SEE IF THE PAIN SUBSIDES BEFORE BEING REFERRED TO ANOTHER ORTHOPEDIC GROUP. THE PATIENT CONTINUED TO EXPERIENCE PERSISTENT PAIN. ADDITIONAL INFORMATION WAS RECEIVED ON 11/13/2025: THE PATIENT CONSULTED WITH ANOTHER ORTHOPEDIC SURGEON AND HAND SPECIALIST. ACCORDING TO THE PATIENT, THE SURGEON EXAMINED AND X-RAYED THE RIGHT THUMB AND CONFIRMED FAILURE OF THE PREVIOUS TIGHTROPE PROCEDURE. PER THE PATIENT REPORT, THE SURGEON RECOMMENDED TO REMOVE THE FAILED TIGHTROPE MATERIALS AND RE-PERFORM THE PROCEDURE USING ARTHREX TIGHTROPE PRODUCTS. IF THE REVISED PROCEDURE IS UNSUCCESSFUL, THE PLAN IS TO HARVEST A TENDON FROM THE PATIENT'S FOREARM TO RECONSTRUCT THE THUMB JOINT. THE REVISION SURGERY IS SCHEDULED FOR ON (B)(6) 2025.

Additional Manufacturer Narrative

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