BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR,SLAP,4.5MM DSPL,DYO PWR /6

    MDR report key: 5967735 · Received September 21, 2016

    Report

    Report Number
    1219602-2016-00816
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    June 11, 2015
    Report Date
    July 8, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE REPORTED COMPLAINT. THE HOODED PORTION OF THE OUTER SHEATH HAS BROKEN OFF AT THE WELDMENT. CONTACT POINTS ON A SECTION OF THE BROKEN HOOD WERE OBSERVED. THE BREAK SHOWS SPLAYING AT THE HOOD AND SHEATH, CONSISTENT WITH EXCESSIVE SIDE LOADING DURING USE. FUNCTIONAL INSPECTION WAS PERFORMED AND THE INNER BURR ROTATED FREELY WITHIN THE OUTER BLADE, NO FRICTION WAS FELT IN THE UNLOADED CONDITION. THE DEVICE WAS INSPECTED DIMENSIONALLY AND FOUND TO MEET DESIGN REQUIREMENTS. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS IDENTIFIED TO BE EXCESSIVE FORCE PLACED ON THE DEVICE DURING USE. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING USE. THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL SITE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618280 BURR,SLAP,4.5MM DSPL,DYO PWR /6 SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC. 50773505

    Patients

    Seq Age Sex Outcome Treatment
    1