BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBOTRIMMER BLADE

    MDR report key: 3070970 · Received April 22, 2013

    Report

    Report Number
    1219602-2013-00091
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE RETURNED DEVICE WAS EVALUATED FOR SHEDDING AND IT WAS OBSERVED THAT THE OUTER BLADE RUNOUT WAS MEASURED TO BE .106". THIS IS 7 TIMES THE MAXIMUM DESIGN TOLERANCE AND RESULTED IN A MISALIGNMENT OF THE INNER AND OUTER BLADES. IT WAS ALSO OBSERVED THAT THERE WAS FRICTION PRESENT WHEN DISASSEMBLING THE INNER BLADE FROM THE OUTER BLADE. THE BLADE IS FOUND TO BE BENT, RESULTING IN SHEDDING. A BEND OF THIS MAGNITUDE IS TYPICALLY CAUSED BY EXCESSIVE LATERAL LOAD BEING APPLIED DURING USE. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT CONFIRMED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN FILED AND THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. (B)(6).

    Description of Event or Problem · 1

    WHILST SHAVING THE MENISCUS INSIDE THE KNEE JOINT, BITS OF METAL WERE COMING OFF THE SHAVER BLADE INTO THE JOINT, AND STICKING TO THE MENISCUS/AREA BEING RESECTED/SHAVED. SOME OF THE PIECES WERE ABLE TO BE REMOVED, BUT NOT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172201 TURBOTRIMMER BLADE BOXED TURBOTRIMMER BL,4.5 MM/6 HAB SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE 50710451

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR