BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR FT SCRW,2.5 MICRO,28MM LGTH

    MDR report key: 10513517 · Received September 10, 2020

    Report

    Report Number
    1220246-2020-02142
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 10, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867126923
    PMA / PMN Number
    K150456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 A TALUS FRACTURE REPAIR, AFTER INSERTION OF THE SECOND SCREW THE TIP OF THE AR-8737-37 BROKE OFF INSIDE THE SCREW HEAD. ALL BROKEN PIECES WERE REMOVED AND AN AR-8737-61 (EASY OUT) WAS USED AND THE SCREW WAS STRIPPED. THE SURGEON COMPLETED THE CASE BY USING A BURR AND SHAVING THE AR-8725-28H SCREW (LOT 10061591) DOWN FLUSH WITH THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977750 COMPR FT SCRW,2.5 MICRO,28MM LGTH PLATE, FIXATION, BONE HRS ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,28MM LGTH 10061591 00888867126923

    Patients

    Seq Age Sex Outcome Treatment
    1 Other