BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2090671 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01298
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS DUPLICATED. UPON DISASSEMBLY OF THE DEVICE, A DAMAGED PRESS PLUG, MOTOR, ROTOR, BEARINGS AND OTHER COMPONENT PARTS WERE NOTED. THE FAULTY PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER SAGITTAL SAW WAS SENT IN FOR REPAIR DUE TO OVERHEATING. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK