BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 3242413 · Received July 23, 2013

    Report

    Report Number
    1045834-2013-03583
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    November 15, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM THAT THE CUTTER CANNOT BE INSERTED WAS CONFIRMED. THE CUTTING BURR COULD NOT BE LOCKED INTO THE ATTACHMENT DUE TO DAMAGE TO THE PAWL CLAMP. THIS DAMAGE IS CONSISTENT WITH THE DEVICE BEING OPERATED WITH A CUTTING BUR THAT WAS NOT FULLY SEATED AND LOCKED INTO THE ATTACHMENT DUE TO IMPROPER ASSEMBLY. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) THAT CUTTER COULD NOT BE INSERTED INTO THE DEVICE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF THE EVENT WAS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344220 11CM ANGLE ATTACHMENT, BLACK MAX MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1