BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL BONE SCREW, Ø3.5MM X 40MM

    MDR report key: 15834812 · Received November 21, 2022

    Report

    Report Number
    1220246-2022-05779
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 30, 2022
    Report Date
    November 21, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665033274
    PMA / PMN Number
    K132005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) 8110-040 CORTICAL SCREW HEAD BROKE UPON INSERTION. THIS WAS DISCOVERED DURING AN ORIF PROX. HUMERAL FX PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601792 CORTICAL BONE SCREW, Ø3.5MM X 40MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. CORTICAL BONE SCREW, Ø3.5MM X 40MM 00848665033274

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown