BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 3013488 · Received March 20, 2013

    Report

    Report Number
    0001811755-2013-00569
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE OF THE DEVICE WOBBLING WAS ATTRIBUTED TO CORRODED AND SHATTERED BEARINGS.THE DEVICE MANUFACTURED DATE CANNOT BE DETERMINED BECAUSE THE SERIAL NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS CAUSING A BUR TO WOBBLE DURING PERFORMANCE TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116538 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGICAL DRILL ERL STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BUR