BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 3242803 · Received July 23, 2013

    Report

    Report Number
    1045834-2013-03588
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    November 14, 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 WAS NOT CONFIRMED; A CUTTING BUR COULD BE INSERTED AND LOCKED INTO THE ATTACHMENT. HOWEVER, THE BEARINGS AND GEARS IN THE ELBOW AND BASE WERE CORRODED AND DAMAGED, AND THE UNIT WOULD NOT ROTATE. THIS CONDITION IS INDICATIVE OF IMPROPER OR INEFFECTIVE CLEANING AND MAINTENANCE OF THE EQUIPMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE LOCKING MECHANISM IS DAMAGED. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343178 11CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1