BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BTB TIGHTROPE W/ DEPLOYING SUTURE

    MDR report key: 19072842 · Received April 9, 2024

    Report

    Report Number
    1220246-2024-01919
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    June 15, 2022
    Report Date
    April 9, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    UDI-DI
    00888867095366
    PMA / PMN Number
    K112990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    501

    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 MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO USER-APPLIED MECHANICAL FORCES TO THE CONSTRUCT DURING USE.

    Description of Event or Problem · 0

    ON 06/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1588BTB-J TIGHTROPE DID NOT SEAT CORRECTLY DURING A PROCEDURE. THE TIGHTROPE BUTTON WAS FLIPPED ONTO THE FEMORAL CORTEX AND SHORTENED AS THE BONE BLOCK ENTERED THE TUNNEL. THE TIGHTROPE THEN WOULD NOT SHORTEN ANY FURTHER CAUSING THE BUTTON TO NOT FULLY SEAT ON THE BONE. THE TIGHTROPE WAS REMOVED BY THE SURGEON CUTTING THE SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423964 BTB TIGHTROPE W/ DEPLOYING SUTURE SMOOTH FIXATION PIN HTY ARTHREX, INC. BTB TIGHTROPE W/ DEPLOYING SUTURE 13715917 00888867095366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown