BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUAD TENDON STRIPPER- CUTTER

    MDR report key: 21060389 · Received January 2, 2025

    Report

    Report Number
    1220246-2025-09178
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 6, 2024
    Report Date
    May 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867098244
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-2384 QUAD TENDON-STRIPPER CUTTER BATCH NUMBER: 012423 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED DAMAGE TO ONE OF THE SPRINGS. FUNCTIONAL TESTING WAS ATTEMPTED, AND IT WAS FOUND THAT THE DEVICE WAS MET WITH RESISTANCE WHEN ACTUATED MAKING IT DIFFICULT TO USE AS INTENDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO MISHANDLING/USER ERROR DUE TO EXCESSIVE MECHANICAL FORCES BEING APPLIED DURING USE. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A SALES REPRESENTATIVE, VIA (B)(4), REPORTED THAT AN AR-2384 QUAD TENDON-STRIPPER CUTTER BROKE DURING A CASE. THIS DID NOT AFFECT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554111 QUAD TENDON STRIPPER- CUTTER MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. QUAD TENDON STRIPPER- CUTTER 012423 00888867098244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown