BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BURR

    MDR report key: 2132891 · Received June 17, 2011

    Report

    Report Number
    1219602-2011-00097
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MAUDE EVENT REPORT INDICATES PATIENT WAS SCHEDULED FOR SHOULDER ARTHROSCOPY. SURGEON WAS DOING THE PROCEDURE AND WAS USING THE ARTHROSCOPIC SHAVER AND NOTICED ON THE SCREEN THAT THERE WAS METAL FRAGMENTS COMING OFF THE SHAVER. IT IS UNKNOWN WHETHER THE SURGEON FLUSHED OUT THE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE BURR ACROMIONIZER,4.0 EP-1,DSPL BL HAB SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7205326 50561156

    Patients

    Seq Age Sex Outcome Treatment
    1