BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CAST CUTTER

    MDR report key: 1960757 · Received December 16, 2010

    Report

    Report Number
    1811755-2010-02039
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN EVALUATION IS ANTICIPATED. THE RECORD WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS HEATING UP AND SMELLED LIKE IT WAS BURNING. CUSTOMER STATED DEVICE WAS USED WHEN REMOVING A CAST. THERE WERE NO ADVERSE CONSEQUENCES TO EITHER USER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR CAST CUTTER SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM HWE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK