BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 4223070 · Received November 4, 2014

    Report

    Report Number
    1045834-2014-14832
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    June 13, 2014
    Report Date
    October 20, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. 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

    : DURING SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER ADDITIONAL INFORMATION WAS RECEIVED. THE CUSTOMER REPORTED THAT THE SURGERY WAS DELAYED ABOUT 15 TO 25 MINUTES TO REMOVE ALL PARTS OF THE CRANIOTOME DEVICE AND TO CHECK THROUGH X-RAY TO ENSURE THAT NO FRAGMENTS WERE LEFT IN THE PATIENT. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT ALL MEASURABLE DIMENSIONS MET SPECIFICATIONS. A VISUAL AND DIMENSIONAL ASSESSMENT WAS PERFORMED, WHICH DETERMINED THAT EXCESSIVE FORCE WAS USED, WHICH CAUSED THE LEG OF THE DURA GUARD TO BEND AND THE FOOT TO FRACTURE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT APPEARED THAT THE DEVICE WAS USED AS A LEVER. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO EXCESSIVE FORCE, WHICH IS MISUSE, ABUSE AND/OR USER 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 FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CRANIOTOME DEVICE BROKE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    705499 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention