BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20

    MDR report key: 22242372 · Received June 17, 2025

    Report

    Report Number
    0001649390-2025-00440
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 17, 2025
    Manufacturer
    TORNIER INC
    Product Code
    GFG
    UDI-DI
    00846832062492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE DRIVER TIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23290 PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20 BIT, SURGICAL GFG TORNIER INC UNKNOWN 00846832062492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown