BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.9CM ATTACHMENT, BLACK MAX

    MDR report key: 3811262 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13993
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE (B)(6) STATED THE DEVICE HAD DAMAGED BEARINGS. IT IS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF PT OR USER INJURY WAS REPORTED. THE THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524002 5.9CM ATTACHMENT, BLACK MAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1