BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE® II RT, RECON IB¿

    MDR report key: 22063881 · Received May 21, 2025

    Report

    Report Number
    1220246-2025-02155
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867291638
    PMA / PMN Number
    K241235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THAT USER ERROR IS THE MOST LIKELY CAUSE OF THE REPORTED EVENT. DIRECTIONS FOR USE (DFU) DFU-0147-EO TIGHTROPE® DEVICES SECTION G. PRECAUTIONS. 1. ACL/PCL/BTB/RT/ABS TIGHTROPE ONLY: EXCESSIVE FORCE ON THE SHORTENING SUTURE STRANDS AND/OR TENSIONING THE SHORTENING SUTURE STRANDS NOT IN-LINE WITH THE BONE SOCKET MAY BREAK THE STRANDS AND IMPAIR THE ABILITY TO FULLY SEAT THE IMPLANT. NO ADDITIONAL FORCE ON THE SHORTENING SUTURE STRANDS IS REQUIRED WHEN THE GRAFT/WEDGE CONSTRUCT REACHES THE DESIRED POSITION IN THE FEMORAL SOCKET AND THE GRAFT STABILITY IS VERIFIED BY PULLING DISTALLY ON THE GRAFT. 2. LOAD THE ACL/PCL TIGHTROPE BUTTON OVER THE UNSPLICED, THINNER PORTION OF THE ACL/PCL TIGHTROPE SUTURE TO ASSIST ASSEMBLY. ONCE ASSEMBLED, SLIDE THE ACL/PCL TIGHTROPE BUTTON DOWN TO THE THICKER, SPLICED PORTION OF THE ACL/PCL TIGHTROPE SUTURE TO HELP PREVENT DISASSEMBLY. 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 ON-SITE DEMONSTRATION. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURE, WHICH SHOWS THE DEVICE WITH THE SUTURE STRANDS BROKEN AND FRAYED. A POSSIBLE BUMP, WHICH IS USUALLY A SIGN OF EXCESSIVE FORCE/TENSIONING, WAS ALSO NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH TIGHTROPE RT II INTERNAL BRACE SURGERY THE SURGEON WAS SEQUENTIAL TENSIONING THE GRAFT INTO THE FEMUR SOCKET USING ARTERY CLIPS TO GRASP THE SUTURES. AS HE WAS BRINGING THE GRAFT INTO THE SOCKET THE TIGHTROPE SUDDENLY GAVE WAY. THE TIGHTROPE SNAPPED AT THE KNOTLESS MECHANISM. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645360 TIGHTROPE® II RT, RECON IB¿ NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. TIGHTROPE® II RT, RECON IB¿ 15346519 00888867291638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown