BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAST CUTTER

    MDR report key: 3083748 · Received April 29, 2013

    Report

    Report Number
    0001811755-2013-00964
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 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

    DURING THE DEVICE EVALUATION, THE REPORTED EVENT OF SMOKING WAS NOT DUPLICATED. NO FAILURES COULD BE FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAST CUTTER WAS ALLEGEDLY SMOKING DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROCEDURE 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 WAS ALLEGEDLY SMOKING DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROCEDURE 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
    183386 CAST CUTTER SAW, POWERED, AND ACCESSORIES HAB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1