BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BURR

    MDR report key: 2171858 · Received July 22, 2011

    Report

    Report Number
    1219602-2011-00117
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 20, 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

    MEDWATCH REPORT INDICATES THAT SURGEON USING THE ARTHROSCOPIC SURGICAL BLADE ON A FEMALE PATIENT'S SHOULDER (EXACT PHYSICAL LOCATION WITHIN SHOULDER STRUCTURE IS UNKNOWN) WHEN METAL FRAGMENT WAS SEEN IN THE SURGICAL SITE DURING USE. THE TIP OF THE BLADE HAS WHAT APPEARS TO BE A MISSING PORTION ON CLOSE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE BURR ACROMIOBLASTER,4.0MM,EP-1,DSPL BLADE HAB SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7205668 50559741

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR