BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW

    MDR report key: 8163616 · Received December 14, 2018

    Report

    Report Number
    3003898228-2018-00021
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    October 22, 2018
    Report Date
    December 7, 2018
    Manufacturer
    FH INDUSTRIE
    Product Code
    LXH
    UDI-DI
    03661489646836
    PMA / PMN Number
    D114497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A REVISION RSA USING CUSTOM IMPLANTS AND V12 INSTRUMENT SET, WE WERE NOT ABLE TO GET THE GLENOSPHERE SCREW TO FULLY ENGAGE WITH METAL BACK GLENOID (SIZE 46 LP). GLENOSPHERE AND FH METAL BACK GLENOID HAD TO BE REMOVED AND REPLACED WITH DJO ENCORE BASEPLATE AND GLENOSPHERE. FH STEM STAYED IN PLACE AND CUSTOM HUMERAL HEAD (B)(4) WAS IMPLANTED ((B)(4)) AFTER THE CASE IT WAS DISCOVERED THAT DUE TO V12 SCREWDRIVER'S TAPERED DESIGN, IT IS IMPOSSIBLE FOR THE SCREWDRIVER TO FULLY GO DOWN SCREW SHAFT ON 44 IMPLANT. NO CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004870 ARROW ARROW SCREWDRIVER 3.5 LXH FH INDUSTRIE 03661489646836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other