BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.6CM TAPERED ATTACHMENT, BLACK MAX

    MDR report key: 3130512 · Received May 24, 2013

    Report

    Report Number
    1045834-2013-02200
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS NOT RECEIVED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA REGARDING AN ATTACHMENT DEVICE IN WHICH AN UNKNOWN MALFUNCTION WAS OBSERVED. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE OR IF ANY DELAYS IN SURGERY WERE REPORTED. IT WAS UNKNOWN TO THE REPORTER IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT WAS UNKNOWN TO THE REPORTER. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232675 12.6CM TAPERED ATTACHMENT, BLACK MAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY- ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1