BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES

    MDR report key: 1908931 · Received November 19, 2010

    Report

    Report Number
    MW5018297
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 19, 2010
    Manufacturer
    SYNTHES, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, ORBITOTOMY OF THE RIGHT EYE, THE SURGEON WAS DRILLING INTO THE ORBIT WITH A DRILL FROM THE SYNTHES MAXILLOFACIAL MICRO SET, AND THE TIP OF THE DRILL BIT BROKE OFF INTO THE ORBITAL RIM. IT WAS DECIDED TO LEAVE THE PIECE OF THE DRILL BIT IN THE BONE, BECAUSE TRYING TO REMOVE IT WOULD HAVE DESTROYED THE BONE. DATES OF USE: APPROX 1 HOUR (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: TO DRILL INTO BONE FOR SCREW PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES 3 MM DRILL BIT HTW SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other