BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 11231539 · Received January 26, 2021

    Report

    Report Number
    1220246-2021-02504
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    December 22, 2020
    Report Date
    January 26, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K201132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AR-8737-38 HEXALOBE DRIVER STRIPPED WHILE REMOVING HARDWARE. ADDITIONAL INFORMATION RECEIVED ON 1/13/2021: THE REP REPORTED THE DRIVERS STRIPPED DURING A LEFT KNEE HARDWARE REMOVAL. THE REASON FOR THE REVISION SURGERY WAS FOR AN OCD REPAIR. ARTHREX COMPRESSION FT SCREWS (AR-8730-XXH) WERE REMOVED DURING THE REVISION SURGERY. THE SPECIFIC PART NUMBERS AND SIZES OF THE EXPLANTED ARTHREX PRODUCT IS CURRENTLY UNKNOWN. THE REP STATED THERE WAS NO ARTHREX PRODUCT IMPLANTED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128087 UNK PLATE, FIXATION, BONE HRS ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other