BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 MM CANNULATED SCREW

    MDR report key: 1770087 · Received July 19, 2010

    Report

    Report Number
    1770087
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 19, 2010
    Manufacturer
    SYNTHES, INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ARTHRODESIS OF RIGHT MIDDLE FINGER DISTAL INTERPHALANGEAL JOINT (DIP) JOINT, A SYNTHES CANNULATED SCREW STARTED TO BEND WITH INSERTION AND UPON RETRIEVAL IT BROKE. IN ORDER TO RETRIEVE THE SCREW, THE CORTEX HAD TO BE BREACHED. THE ARTHRODESIS PROCEEDED WITH A 30 MM LONG THREAD 3-0 SCREW FROM SYNTHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0 MM CANNULATED SCREW SKELETAL FIXATION SCREW HWC SYNTHES, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR