BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 10666941 · Received October 12, 2020

    Report

    Report Number
    1220246-2020-02228
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 12, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K170382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    501

    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 THE TIPS ON A QUANTITY TWO AR-8750-03, DRIVER SHAFTS HAVE BROKEN OFF. SEE SOURCE DATA ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 09/24/2020: THE REP REPORTED THE TYPE OF PROCEDURE TAKING PLACE WAS A HARDWARE REMOVAL. THE TWO AR-8750-03 DRIVERS WERE BEING USED TO REMOVE TWO ARTHREX 5.0 HEADLESS COMPRESSION SCREWS. DURING USE, THE TIPS OF THE DRIVERS BROKE OFF IN THE SCREW HEAD. THE BROKEN TIPS WERE FULLY RETRIEVED USING FORCEPS, AND THE SURGEON THEN USED SOLID DRIVERS TO COMPLETE THE REMOVAL. THE REP REPORTED AT THIS POINT IN TIME THERE IS NO FURTHER INFORMATION REGARDING THE PRIMARY PROCEDURE, OR THE REASON FOR THE HARDWARE REMOVAL. THE PART/LOT NUMBERS OF EXPLANTED ARTHREX PRODUCT IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125074 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other