BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMITH & NEPHEW

    MDR report key: 1781600 · Received July 22, 2010

    Report

    Report Number
    MW5016856
    Event Type
    Other
    Date Received
    July 22, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HRX
    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 5.5 MM INCISOR BLADE. ARTHROSCOPIC SHAVER/BUR 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, 5.5MM INCISOR BLADE HRX SMITH & NEPHEW 50515850
    2 SMITH & NEPHEW ARTHROSCOPIC SURGERY BLADE, 4.0MM STONE CUTTER HRX SMITH & NEPHEW 50515850

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other