BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 4910659 · Received July 13, 2015

    Report

    Report Number
    1045834-2015-11574
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Report Date
    June 18, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THIS WAS CAUSED BY FAILURE TO FOLLOW DIRECTIONS FOR USE. THE BURR DEVICE WAS IMPROPERLY LOADED INTO THE DEVICE AND THEN INSTALLED ONTO THE MOTOR DEVICE. THEREFORE, THE BURR DEVICE DID NOT SEAT PROPERLY IN THE LOCKING CHAMBER. THE DEVICE WAS THEN FORCED INTO POSITION WHICH PLACED THE DISTAL TIP OF THE BURR DEVICE IN COMPRESSION. AT THIS POINT, THE TIP OF THE BURR WAS IN DIRECT CONTACT WITH THE NEURO TIP OF THE DEVICE. WHEN THE MOTOR DEVICE WAS STARTED, THE BURR DRILLED INTO AND BENT THE TIP OF THE DEVICE. THE ASSIGNABLE ROOT CAUSE OF THE COMPONENT DAMAGE WAS DETERMINED TO BE DUE TO MISUSE, ABUSE AND POSSIBLY USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOT PLATE WAS BENT ON THE CRANIOTOME DEVICE. THE EVENT WAS NOT REPORTED TO HAVE OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452851 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1