BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3033105 · Received April 3, 2013

    Report

    Report Number
    0001811755-2013-00684
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE INSIDE OF THE HANDPIECE AND ON THE PINS. IT WAS ALSO FOUND THAT THE SAGHEAD WAS WORN.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE INSIDE OF THE HANDPIECE AND ON THE PINS. IT WAS ALSO FOUND THAT THE SAGHEAD WAS WORN.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137094 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1