BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH & NEPHEW

    MDR report key: 1781609 · Received July 22, 2010

    Report

    Report Number
    MW5016859
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE FOR DISPOSABLE INSTRUMENT 4.0 MM STONE CUTTER AND 5.0 MM INCISOR BLADE. ARTHROSCOPIC SHAVER/BURR DURING USE RESULTED IN METAL FLAKING LEFT IN SHOULDER. SHOULDER SPACE IRRIGATED NO VISUAL RESIDUAL REMAINING. COMPANY NOTIFIED OF DEVICE FAILURE. DATE OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: RCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH & NEPHEW ARTHROSCOPIC SURGERY BLADE, 5.0MM INCISOR BLADE HRX SMITH & NEPHEW 20209475
    2 SMITH & NEPHEW ARTHROSCOPIC SURGERY BLADE, 4.0MM STONE CUTTER HRX SMITH & NEPHEW 20209475

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other