BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3083732 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00950
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 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 BEARING, MOTOR, PRESS PLUGS. ADDITIONALLY THE SAGHEAD HAD NO GAP.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SERVICE AT THE MANUFACTURER THAT THE MICRO SAGITTAL SAW RAN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185401 MICRO SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1