BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REELPASS SUTR LASSO,45° CRV LFT

    MDR report key: 19136021 · Received April 18, 2024

    Report

    Report Number
    1220246-2024-02132
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    February 12, 2021
    Report Date
    April 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867115866
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. COMPLAINT NOT CONFIRMED. VISUAL INSPECTION IDENTIFIED THAT THE SUTURE HAD BEEN PARTIALLY DEPLOYED. DURING FUNCTIONAL TESTING, THE SUTURE WAS ABLE TO BE DEPLOYED ONCE MORE. NO PROBLEM WAS OBSERVED. THE REELPASS WAS DISASSEMBLED TO CHECK FOR PROPER WHEEL ALIGNMENT, AND NO ABNORMALITY WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A BANKART REPAIR OF THE LEFT SHOULDER A QUANTITY TWO AR-6069-45L (LOT: 12221645) MALFUNCTIONED. WHEN THE PRODUCT WAS OPENED, THE SCRUB TECH ATTEMPTED TO RUN THE SUTURE BY ROLLING THE WHEEL TO MAKE SURE IT WORKED BEFORE HANDING IT TO THE SURGEON. THE MONOFILAMENT FROM THE DEVICE CAME OUT ABOUT TWO INCHES AND THEN STOPPED DESPITE CONTINUING TO ROLL THE WHEELS TOGETHER AND INDEPENDENTLY. THE SCRUB TECH THEN TOOK A HEMOSTAT AND TRIED TO PULL THE SUTURE OUT THE TIP AS WELL AS ROLL THE WHEEL TO GET THE SUTURE TO RUN BUT IT STILL DID NOT FEED. A SECOND DEVICE WAS OPENED TO REPLACE THE FIRST ONE BUT THE EXACT SAME THING HAPPENED AS THE FIRST. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER MANUFACTURER'S DEVICE. SEE SOURCE DATA ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270012 REELPASS SUTR LASSO,45° CRV LFT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. REELPASS SUTR LASSO,45° CRV LFT 12221645 00888867115866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown