BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER

    MDR report key: 3192083 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01471
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENTS OF HEATING UP AND RUNNING TOO FAST WERE NOT DUPLICATED. NO FAILURES WERE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAST CUTTER ALLEGEDLY OVERHEATED AND RAN TOO FAST DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAST CUTTER ALLEGEDLY OVERHEATED AND RAN TOO FAST DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293380 CAST CUTTER SAW, POWERED, AND ACCESSORIES HAB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1