BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH

    MDR report key: 4275323 · Received October 2, 2014

    Report

    Report Number
    4275323
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US

    Narratives

    Description of Event or Problem · 1

    DURING A CRANIAL SURGERY - THE DEPUY ANSPACH DRILL BIT BROKE.A SMALL PIECE / FRAGMENT OF BIT WAS APPERENTLY NOT FOUND DURING SURGERY. HOWEVER UPON FOLLOW UP MRI - THE METAL FRAGMENT FROM DRILL BIT WAS FOUND IN A CT AS AN ARTIFACT.THE RISK WOULD HAVE BEEN IF THE PATIENT RECIEVED AN MRI AS WOULD BE NORMAL FOLLOW UP PROCEDURE FOR THE SURGERY COMNPLETED - A RISK OF HEAT OR RUPTURE COULD HAVE OCCURRED AS MATERIAL WAS FERROUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614042 ANSPACH DRILL HBE SYNTHES (USA) PRODUCTS LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR