BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5CM ADULT CRANI ATTACHMT

    MDR report key: 4123322 · Received September 26, 2014

    Report

    Report Number
    1045834-2014-13095
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 9, 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

    DEVICE EVALUATION UPDATE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A VISUAL ASSESSMENT WAS PERFORMED WHICH FOUND THAT THE DURA GUARD WAS BROKEN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER LOADING OF THE BURR INTO THE MOTOR, WHICH IS MISUSE, ABUSE AND POSSIBLY USER ERROR. 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

    A CONTACT NAME, ADDRESS AND PHONE NUMBER WAS NOT PROVIDED. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 NOT RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER SENT A PHOTOGRAPHIC PICTURE FOR EVALUATION. RELIABILITY ENGINEERING REVIEWED THE PHOTOGRAPHIC IMAGE AND DETERMINED THAT THE TIP OF THE DEVICE WAS BROKEN WHILE DRILLING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO EXCESSIVE FORCE BEING PLACED ON THE DEVICE DURING USE, WHICH IS MISUSE. 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 THE TIP OF THE CRANIOTOME DEVICE BROKE ¿WHILE DRILLING¿. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. THE REPORTER DID NOT SPECIFY WHAT TYPE OF MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. 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
    602857 6.5CM ADULT CRANI ATTACHMT MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention