BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE KIT FOR 1.8 MM Q-FIX IMP

    MDR report key: 4355712 · Received December 18, 2014

    Report

    Report Number
    3006524618-2014-00350
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 19, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE USING A DISPOSABLE KIT FOR 1.8 MM Q-FIX IMPLANT, THE SURGEON ALLEGED THAT THE BLACK BEARING SHEATH THAT THE DRILL GOES THROUGH APPEARS TO HAVE WELDED TO THE DRILL, BREAKING DRILL PROXIMALLY. AS A RESULT OF THIS DEFICIENCY, ADDITIONAL Q-FIX IMPLANTS NEEDED TO BE USED, INCLUDING THE ONE THAT WAS ABANDONED WITHOUT FUNCTION IN THE BONE. THE SURGEON ADVISED OF A POSSIBLE COMPLICATION STEMMING FROM THE IMPLANT THAT WAS ABANDONED IN THE BONE. THERE HAVE BEEN NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835049 DISPOSABLE KIT FOR 1.8 MM Q-FIX IMP ORTHOPEDIC INTERNAL FIXATION SYSTEMS MBI ARTHROCARE CORPORATION 1073800

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other