BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE KIT, HIP, FOR 1.8MM Q-FIX IMP

    MDR report key: 4218992 · Received August 7, 2014

    Report

    Report Number
    3006524618-2014-00239
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE USING A DISPOSABLE 1.8 MM Q-FIX IMPLANT KIT, THE DRILL BIT GOT STUCK IN THE DRILL GUIDE AND THEN BROKE OFF. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463562 DISPOSABLE KIT, HIP, FOR 1.8MM Q-FIX IMP FIXATION ANCHOR, LIGAMENT, NON-BIODEGRADABLE MBI ARTHROCARE CORPORATION 1065504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other