BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS INCISOR PLUS ELITE

    MDR report key: 2797370 · Received September 23, 2012

    Report

    Report Number
    2797370
    Event Type
    Malfunction
    Date Received
    September 23, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 23, 2012
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    METAL SHAVINGS WERE SEEN IN THE PATIENT JOINT FOLLOWING PRODUCT USE. THE DEVICE IS PART OF AN ARTHROSCOPIC RESECTION SYSTEM.======================MANUFACTURER RESPONSE FOR DYONICS ARTHROSCOPY SURGERY BLADE, DYONICS ARTHROSCOPY SURGERY BLADE (PER SITE REPORTER).======================SWITCHED OUT THE REMAINING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS INCISOR PLUS ELITE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL HRX SMITH & NEPHEW 7210976 50650501

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR