BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE ® II BTB WITH DEPLOYING SUTURE

    MDR report key: 19312016 · Received May 14, 2024

    Report

    Report Number
    1220246-2024-03250
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    July 9, 2021
    Report Date
    May 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867319660
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON PULLED THE #2 STRAND INTO #3, HE NOTICED THE SUTURES HAD INTERTWINED INTO THEMSELVES. THE SPLICE WORKED CORRECTLY BUT NOTICED THAT IT LOOKED LIKE THEY HAD AN EXTRA LOOP LOCKING THE 2 LOOPS TOGETHER. THE SURGEON CUT OFF THE AR-1588BTB-2J AND USED AN OLD BTB-J TO COMPLETE THE CASE. THE DEVICE DID NOT BREAK DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547379 TIGHTROPE ® II BTB WITH DEPLOYING SUTURE NON-DEGRADABLE FIXATION FASTENER MBI ARTHREX, INC. TIGHTROPE ® II BTB WITH DEPLOYING SUTURE 12636356 00888867319660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown