BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 2510635 · Received March 26, 2012

    Report

    Report Number
    MW5024795
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 26, 2012
    Manufacturer
    SYNTHES, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    S/P ORIF LEFT TIB/FIB FX., (1) SYNTHES 212 SERIES 3.5MM LOCKING SCREW. AND (5) SYNTHES 02.200 SERIES 3.5MM CORTEX SCREWS WERE NOTED TO BE BROKEN. THE MAJORITY OF THE HARDWARE WAS REPLACED, WHICH UNINTENTIONAL RETENTION OF SEVERAL OF THE BROKEN PORTIONS OF THE SCREWS WITHIN THE TIBIA. REASON FOR USE: TIB/FIB FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES LOCKING SCREW HWC SYNTHES, INC. 212
    2 SYNTHES CORTEX ORTHOPEDIC SCREWS HWC SYNTHES, INC. 02.200 SERIES
    3 SYNTHES CORTEX ORTHOPEDIC SCREWS HWC SYNTHES, INC. 02.200 SERIES
    4 SYNTHES CORTEX ORTHOPEDIC SCREWS HWC SYNTHES, INC. 02.200 SERIES
    5 SYNTHES CORTEX ORTHOPEDIC SCREWS HWC SYNTHES, INC. 02.200 SERIES
    6 SYNTHES CORTEX ORTHOPEDIC SCREWS HWC SYNTHES, INC. 02.200 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability