BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HUM NAIL 7X220MM

    MDR report key: 1930246 · Received November 24, 2010

    Report

    Report Number
    1818910-2010-08840
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    DEPUY ACE S.A.'R.L.
    Product Code
    HSB
    PMA / PMN Number
    K033878
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NAIL NEEDS TO BE REMOVED FOR NON UNION. NOTHING WOULD SCREW INTO THE TOP OF NAIL TO GET IT OUT EXTENDING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HUM NAIL 7X220MM 87 HSB HSB DEPUY ACE S.A.'R.L. NA DFLB6N000

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR