BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLE DRIVER

    MDR report key: 3160091 · Received June 10, 2013

    Report

    Report Number
    1045834-2013-02416
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    July 19, 2011
    Report Date
    July 25, 2011
    Manufacturer
    DEPUY SYNTHES
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE WAS EVALUATED AND THE CONDITION WAS CONFIRMED. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM U.S.A. STATING THAT THE DEVICE WOULD NOT ROTATE OR SPIN. THIS DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF THERE WAS ANY USER OR PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260918 ANGLE DRIVER DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) ATTACHMENT HBE DEPUY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly