BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 4180688 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13311
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    June 12, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE BEARINGS WERE DAMAGED AND THE DEVICE OVERHEATED. THIS WAS ATTRIBUTED TO NORMAL WEAR. MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON 06/27/2013.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN FOUND BEARING WORN FROM USE, OVERHEAT. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662542 11CM ANGLE ATTACHMENT, BLACK MAX DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1