BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKING SCREW, 1.4X9MM

    MDR report key: 10484081 · Received September 2, 2020

    Report

    Report Number
    1220246-2020-02137
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867303713
    PMA / PMN Number
    K191326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF RIGHT RING FINGER AND SMALL METACARPALS PROCEDURE ONE AR-18714V-09 LOCKING SCREW BROKE DURING INSERTION INTO THE PLATE. UPON FINAL SEATING THE HEAD OF THE SCREW BROKE OFF DURING INSERTION. THE THREADS OF THE BROKEN SCREW ARE REPORTED TO REMAIN IN THE PATIENT UNDER THE PLATE. ALSO DURING THE PROCEDURE TWO T4 DRIVERS (ONE RETAINING AN DONE NON RETAINING) WERE COMPROMISED AND NOT ABLE TO COMPLETE THE FULL CLOCKWISE ROTATIONS NECESSARY FOR FLUSH SEATING OF THE LOCKING SCREW HEADS. THE DRIVERS WERE THE FOLLOWING: AR-18700-29 (LOT 1391940) AND AR-18700-09 (LOT 1391937). THE SURGEON USED JEWELER'S HANDLES (ALL BLACK AND ALL SILVER) WITH THE DRIVERS. ALL SCREWS WERE PRE-DRILLED ON POWER WITH A 1.1MM DRILL AND IMPLANTED VIA MANUAL INSERTION ONLY, USING THE TWO FINGERS TIGHT METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945821 VA LOCKING SCREW, 1.4X9MM PLATE, FIXATION, BONE HRS ARTHREX, INC. VA LOCKING SCREW, 1.4X9MM 1063915 00888867303713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other