BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2231256 · Received July 25, 2011

    Report

    Report Number
    1811755-2011-02668
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION DAMAGE WAS NOTED WITHIN THE INTERNAL COMPONENTS OF THE DEVICE.

    Description of Event or Problem · 1

    THE MICRO RECIPROCATING SAW WAS SENT IN FOR EVALUATION DUE TO OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, NO PROCEDURE DELAY WAS REPORTED. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK