BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS INCISOR PLUS ELITE

    MDR report key: 1961814 · Received December 28, 2010

    Report

    Report Number
    1961814
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 27, 2010
    Report Date
    December 28, 2010
    Manufacturer
    SMITH AND NEPHEW ENDOSCOPY, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADOLESCENT MALE WAS TAKEN TO SURGERY TO REPAIR A RIGHT KNEE LATERAL BUCKET-HANDLE MENISCAL TEAR. DURING ARTHROSCOPY, THE SMITH AND NEPHEW DYONICS ARTHROSCOPIC SURGERY INCISOR PLUS ELITE BLADE GAVE OFF WHAT WAS BELIEVED TO BE SMALL METAL FRAGMENTS IN THE PT'S JOINT. THE SURGEON STOPPED USING THE BLADE AND THOROUGHLY IRRIGATED THE JOINT TO FLUSH OUT ALL THE FRAGMENTS. THE MD WAS ABLE TO USE A DIFFERENT BLADE TO FINISH THE PROCEDURE. THERE WAS NO INJURY TO THE PT. THE BLADE WAS SEQUESTERED AND BAGGED FOR RISK MANAGEMENT PICK-UP. THE PT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE PACU FOR RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS INCISOR PLUS ELITE ARTHROSCOPE, BLADE HRX SMITH AND NEPHEW ENDOSCOPY, INC. 7210976 50551293

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR NONE NOTED