BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL

    MDR report key: 11475260 · Received March 12, 2021

    Report

    Report Number
    1220246-2021-02713
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 12, 2021
    Report Date
    March 12, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313231
    PMA / PMN Number
    K191326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 BY THE SALES REP, THAT DURING A METACARPAL FRACTURE, THE AR-18716-11 BROKE UPON INSERTION. ADDITIONAL INFORMATION PROVIDED 2/26/21: ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CORRESPONDING DRILL BIT FOR THE 1.6MM SCREWS WAS USED PRIOR TO INSERTION (1.2MM DRILL BIT). THE PATIENT WAS IN UPPER 20S WITH HEALTHY BONE QUALITY. AFTER REMOVAL OF THE BROKEN SCREW, A NEW SCREW OF SIMILAR SIZE WAS USED TO COMPLETE PLATE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375434 LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL PLATE, FIXATION, BONE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL 1087547 00888867313231

    Patients

    Seq Age Sex Outcome Treatment
    1