BEUDAMED
    FDA Adverse Event Summary report: N

    SCREW

    MDR report key: 1170692 · Received September 10, 2008

    Report

    Report Number
    1170692
    Date Received
    September 10, 2008
    Date of Event
    July 14, 2008
    Report Date
    September 10, 2008
    Manufacturer
    SYNTHES USA INC.
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SYNTHES CRANIOFACIAL MODULAR FIXATION SET BEING USED FOR BILATERAL SAGITTAL SPLIT MANDIBULAR OSTEOTOMY WITH RIGID INTERNAL FIXATION PROCEDURE. ONE OF THE RED MODULE, 1.5MM (1.5MMX5MM) SCREWS BROKE OFF WHILE THE SURGEON WAS PLACING IT. THE OTHER EIGHT SCREWS USED DURING THE PROCEDURE WERE INTACT. THE SURGEON COULD NOT RETRIEVE THE RETAINED SCREW FROM THE PATIENT'S JAW. IT WAS DETERMINED THAT THE SURGEON'S TECHNIQUE RESULTED IN THE BREAKAGE OF THE SCREW. THE SURGEON WAS INSERVICED ON THE PROPER TECHNIQUE BY ONE OF THE MANUFACTURER'S REPRESENTATIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HWC SYNTHES USA INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR