BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFD100 IMPERIAL TORQUE SCREW

    MDR report key: 5864939 · Received August 10, 2016

    Report

    Report Number
    3003807210-2016-00004
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 10, 2016
    Manufacturer
    IMRIS-DEERFIELD IMAGING, INC.
    Product Code
    HBL
    PMA / PMN Number
    K103493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HFD100 SKULL CLAMP ASSY IMPERIAL TORQUE SCREW IN QUESTION WAS RETURNED FOR EVALUATION. THE TORQUE SCREW WAS FOUND TO BE IN CALIBRATION WHEN RECEIVED FROM THE CUSTOMER. THE TORQUE SCREW WAS PLACED IN THE FORCE GAUGE MEASUREMENT FIXTURE AND TIGHTENED TO THE 60 LB. PRESSURE INDICATION LINE. THE FORCE GAUGE MEASURED 60.2 LBS. BASED ON OUR INVESTIGATION, THE TORQUE SCREW IS FUNCTIONING WITHIN ORIGINAL SPECIFICATION AND OPERATED AS INTENDED. SINCE THERE WAS NO DEVICE MALFUNCTION, THERE IS A POSSIBILITY THAT USER ERROR CAUSED OR CONTRIBUTED TO THE EVENT, EITHER BY NOT PROPERLY EVALUATING THE LOCATIONS OF THE PINS ON THE PATIENT'S SKULL, NOT PINNING THE PATIENT CORRECTLY, OR SETTING THE TORQUE SCREW PRESSURE TOO HIGH. DATA IS NOT AVAILABLE FROM THE HOSPITAL TO ASSESS THE SPECIFIC APPLICATION OF THE SKULL CLAMP TO THIS PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A (B)(6) MALE PATIENT UNDERWENT A CRANIOTOMY FOR TUMOR RESECTION. NEAR THE END OF THE 10-HOUR PROCEDURE, THE SURGEON NOTED A DEPRESSION IN THE PATIENT'S SKULL. A CT WAS PERFORMED ON THE PATIENT, WHICH SHOWED FRACTURES ON BOTH RIGHT AND LEFT SIDES OF THE SKULL WHERE THE PINS HAD BEEN PLACED. THE SURGEON WAS CONCERNED THAT THE TORQUE PRESSURE GAGE (ORIGINALLY SET TO 60 LBS.) MAY HAVE BEEN INACCURATE. THIS UNIT IS FREQUENTLY USED AND THERE HAD BEEN NO PROBLEMS WITH IT PRIOR TO THIS INCIDENT. ACCORDING TO THE HOSPITAL'S RISK MANAGEMENT TEAM, THE PATIENT IS DOING WELL AND IS NEUROLOGICALLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518039 HFD100 IMPERIAL TORQUE SCREW HEAD HOLDER (SKULL CLAMP) HBL IMRIS-DEERFIELD IMAGING, INC. 111236-000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening