BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.25CM ATTACHMENT, BLACK MAX

    MDR report key: 3122386 · Received May 21, 2013

    Report

    Report Number
    1045834-2013-02143
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 19, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ATTACHMENT DEVICE WAS RECEIVED FOR EVALUATION. THE ATTACHMENT DEVICE WAS TESTED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATED THIS WAS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA IN WHICH IT WAS DISCOVERED THAT AN ATTACHMENT DEVICE WAS "BROKEN". IT WAS UNKNOWN TO THE REPORTER WHEN THE ALLEGED DEFECT OCCURRED. IT WAS UNKNOWN TO THE REPORTER IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE DATE OF THE EVENT WAS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225110 11.25CM ATTACHMENT, BLACK MAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY- ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1