BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 3961123 · Received July 28, 2014

    Report

    Report Number
    1045834-2014-12494
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE TIP WAS BENT AND HAD BEEN DRILLED INTO. IT WAS DETERMINED THAT THE BURR WAS IMPROPERLY LOADED INTO THE ATTACHMENT AND THEN INSTALLED ONTO THE DRILL. AS A RESULT, THE BURR DID NOT SEAT PROPERLY IN THE LOCKING CHAMBER. THE DEVICE WAS THEN FORCED INTO POSITION WHICH PLACES THE DISTAL TIP OF THE BURR IN COMPRESSION, AND THE TIP OF THE BURR WAS IN DIRECT CONTACT WITH THE TIP OF THE DEVICE. WHEN THE DRILL WAS STARTED, THE BURR DRILLED INTO OR THROUGH THE TIP OF THE DEVICE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO FAILURE TO FOLLOW THE DIRECTIONS FOR USE, WHICH IS MISUSE, ABUSE AND/OR ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ENGINEERING EVALUATION, IT WAS DISCOVERED THAT THE CRANIOTOME DEVICE HAD A BENT TIP. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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
    439254 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1