BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CN ABGKE ATTACHMENT

    MDR report key: 3564380 · Received August 30, 2013

    Report

    Report Number
    1045834-2013-08955
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Date of Event
    March 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THERE WAS NOISE ASSOCIATED WITH THIS DEVICE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432756 8CN ABGKE ATTACHMENT MOTOR, DRILL, ELECTRIC-ATTACHMENT, PRODUCT CODE HBC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1