BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 3111890 · Received May 14, 2013

    Report

    Report Number
    1045834-2013-02123
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE ATTACHMENT DEVICE'S "BEARINGS WERE RATTLING AND THE BURRS WERE NO SEATING CORRECTLY" AND "THE DRILL BIT WAS IN THE ATTACHMENT AND GETS STUCK" DURING POST STERIA CEREBRAL FUSION SURGERY. THE REPORTER STATED THAT THERE WAS A DELAY BUT A SPECIFIC TIME WAS UNKNOWN. THERE WAS A LONG ENOUGH DELAY TO GET AN IDENTICAL ATTACHMENT DEVICE FOR USE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213607 11.0 CM LONG ATTACHMENT MOTOR, DRILL, ELECTRIC-ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR