BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT CRANIOTOME

    MDR report key: 7064853 · Received November 28, 2017

    Report

    Report Number
    1045834-2017-50027
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 30, 2017
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    HBC
    UDI-DI
    00845384016410
    PMA / PMN Number
    K133604
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTER'S PHONE NUMBER: (B)(6). 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 RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. A VISUAL AND FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH FOUND THAT THE NEURO-TIP LEG HAD BEEN DRILLED INTO AND THE NEURO-TIP LEG WAS BENT. IT WAS DETERMINED THAT THIS WAS DUE TO EXCESSIVE LATERAL FORCE PLACED ON THE DEVICE CAUSING THE DRILL TO FLEX AND COME INTO CONTACT WITH THE NEURO-TIP LEG AND BENDING THE LEG. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED NEUROLOGICAL SURGICAL PROCEDURE IT WAS OBSERVED THAT METAL DEBRIS, ASSUMED TO BE PIECES FROM THE CRANIOTOME ATTACHMENT DEVICE, FELL OUT AND FELL INTO THE PATIENT. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE DEBRIS WAS RETRIEVED FROM THE PATIENT HOWEVER, IT WAS UNKNOWN HOW THE DEBRIS WAS RETRIEVED. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PATIENT CONDITION IS UNKNOWN. THERE WERE NO REPORTS OF INJURIES, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844689 ADULT CRANIOTOME MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC THE ANSPACH EFFORT LLC CRANI-A-G1 00845384016410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention