BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HIP BURRS

    MDR report key: 1961939 · Received January 15, 2011

    Report

    Report Number
    1219602-2011-00016
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BURR SHED DURING USE. ADDITIONAL INFORMATION STATED THE BURR STARTED TO SHED IMMEDIATELY AND THAT THE SURGEON ATTEMPTED TO REMOVE ALL THE PARTICULATE BUT PROBABLY NOT ALL OF IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HIP BURRS BURR,4.0MM ABRADER,180MML DISPOSABLE (3 HAB SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 72200080 20144267

    Patients

    Seq Age Sex Outcome Treatment
    1