BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2771477 · Received September 28, 2012

    Report

    Report Number
    1811755-2012-03678
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, THE BEARINGS WERE DISCOVERED TO BE DAMAGED AND THE MOTOR WAS CORRODED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A MICRO SAGGITAL SAW OVERHEATED. THE ACCOUNT WAS UNABLE TO PROVIDE DETAIL AS TO WHICH SPECIFIC HAND PIECE OVERHEATED, AS SEVERAL WERE PUT INTO A REPAIR BIN TOGETHER. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW HBE STRYKER INSTRUMENTS, INSTRUMENTS DIV.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MICRO SAGGITAL SAW: SN (B)(4)