BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX MOTOR ASSY

    MDR report key: 3811901 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-06705
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES. THE DEVICE IS CURRENTLY UNDERGOING EVALUATION. ONCE THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING WHEN THE USER "WENT TO USE THE DRILL AND THE FOOT PEDAL WAS PRESSED, THE DRILL MADE A VERY LOUD WHINING NOISE AND WOULD NOT SPIN BURR". THE DEVICE WAS BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523821 MICROMAX MOTOR ASSY DRILL, SURGICAL, ENT (PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1