BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWANSON PILOT POINT BUR

    MDR report key: 3043544 · Received April 9, 2013

    Report

    Report Number
    0001811755-2013-00730
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS INDICATE THAT WHEN THE BUR WAS IN USE, IT MAY HAVE COME INTO CONTACT WITH THE RETRACTOR. IF A BUR COMES INTO CONTACT WITH A HARD METAL INSTRUMENT SUCH AS A RETRACTOR, THIS CAN POTENTIALLY CAUSE THE BUR TO FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED, THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE AT THE SHAFT DURING A BUNION ARTIFICIAL JOINT REPLACEMENT SURGERY. THERE WAS A REPORTED DELAY OF AN FEW EXTRA MINUTES TO GET THE BROKEN BUR OUT OF THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR BROKE AT THE SHAFT DURING A BUNION ARTIFICIAL JOINT REPLACEMENT SURGERY. THERE WAS A REPORTED DELAY OF AN FEW EXTRA MINUTES TO GET THE BROKEN BUR OUT OF THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146812 SWANSON PILOT POINT BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER INSTRUMENTS-KALAMAZOO 12318017

    Patients

    Seq Age Sex Outcome Treatment
    1