BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20

    MDR report key: 25150527 · Received May 12, 2026

    Report

    Report Number
    0001649390-2026-00416
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 12, 2026
    Manufacturer
    TORNIER INC
    Product Code
    GFG
    UDI-DI
    00846832062492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    DRIVER TIP BROKE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184142 PERFORM REVERSED PERIPHERAL AND SPHERE SCREWDRIVER BIT T20 BIT, SURGICAL GFG TORNIER INC UNKNOWN 00846832062492

    Patients

    Seq Age Sex Outcome Treatment
    1