BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT SCREWDRIVER

    MDR report key: 6342677 · Received February 20, 2017

    Report

    Report Number
    1020279-2017-00110
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    January 24, 2017
    Report Date
    June 8, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LRZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SCREWDRIVERS AND SCREW WERE ALL STRIPPED WHILE TRYING TO REMOVE THE ACETABULAR SCREW, THEREFORE, BOTH SCREWDRIVER SHAFTS WERE REPLACED AND THE SCREW WAS REMOVED UTILIZING A MIDAS-REX BURR. THE SURGERY TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125282 STRAIGHT SCREWDRIVER SCREWDRIVER, SURGICAL LRZ SMITH & NEPHEW, INC. 71362293 01JM06391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACETABULAR SCREW: NI, LOT NI| T-HANDLE: 71364006, LOT 00804454