BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW WITH XL BLADE MOUNT

    MDR report key: 3000436 · Received March 12, 2013

    Report

    Report Number
    0001811755-2013-00505
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL EXAMINATION, THE BEARINGS WERE FOUND TO BE GRITTY AND CORROSION WAS DISCOVERED INSIDE THE MOTOR. IN ADDITION, THE HOUSING AND ADAPTOR WERE WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICRO OSCILLATING SAW WITH XL BLADE MOUNT OVERHEATED AND RAN WITHOUT USER ACTIVATION DURING A PROCEDURE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103572 MICRO OSCILLATING SAW WITH XL BLADE MOUNT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1