BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES USA

    MDR report key: 3365724 · Received September 19, 2013

    Report

    Report Number
    MW5031961
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 13, 2013
    Report Date
    September 2, 2013
    Manufacturer
    DEPUY SYNTHES
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS REMOVING HARDWARE FROM PT'S FINGER. THE SURGEON REPORTED THE "SHEERING OFF OF ONE OF THE HEADS OF THE 1.3 SCREWS RETAINING THE SHAFT PORTION OF THE SCREW WITHIN BONE. THERE WAS NO RESIDUAL PROMINENCE. THE SURGEON STATED THAT EFFORTS TO REMOVE THE RETAINED PORTION WOULD HAVE REQUIRED BONE DESTRUCTION. AS A RESULT, HE DETERMINED IT WAS BEST TO LEAVE THE SHAFT PORTION OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472558 SYNTHES USA 1.3 MM TI CORTEX SCREW HWC DEPUY SYNTHES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR