BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QWIX FIXATION SCREW 4.3 DIAMETER X 40MM LENGTH

    MDR report key: 2852529 · Received November 15, 2012

    Report

    Report Number
    9615741-2012-00093
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    PMA / PMN Number
    K071639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DURING A LAPIDUS BUNIONECTOMY PROCEDURE, ON A PATIENT WHO HAD 'HARD BONE,' AFTER 2 QWIX SCREWS WERE PLACED A SHORT DRILL WAS UTILIZED TO PUNCTURE THE PROXIMAL CORTEX OF BONE AND ACCOMMODATE THE HEAD OF THE THIRD SCREW. A THIRD 40MM QWIX SCREW WAS SELECTED AND DRIVEN IN BY POWER ABOUT 1/2 WAY. THE REST OF THE SCREW WAS THEN DRIVEN BY HAND UNTIL THE HEAD BEGAN TO RECESS INTO THE CORTEX OF THE BONE. AS THE HEAD OF THE SCREW BEGAN TO SINK, "A SNAP WAS HEARD" AND THE DOCTOR REMOVED THE DRIVER WITH THE HEAD OF THE SCREW STILL CONNECTED. AFTER AN X-RAY WAS REVIEWED IT WAS DETERMINED THAT THE REMAINDER OF THE SCREW HAD TO BE REMOVED. PLIERS WERE USED TO REMOVE WHAT WAS VISIBLE OF THE BACK OF THE SHAFT OF THE REMAINING SCREW. THE REMAINDER OF THE SCREW CAME APART; ITS DISTAL THREADED PORTION WAS BURIED AND UNRECOVERABLE. A SECONDARY METHOD OF FIXATION WAS NEEDED TO STABILIZE THE FUSION. A SMALL "T" SHAPED SYNTHES PLATE WAS SELECTED AND CUT TO FIT, AND FILLED WITH LOCKING SCREWS. IN ADDITION, 2.5 CC'S OF TRELXPRESS BONE GRAFT WERE ADDED TO THE FUSION SITE FOR BONE INGROWTH CAPABILITIES. SURGERY TIME WAS INCREASED BY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QWIX FIXATION SCREW 4.3 DIAMETER X 40MM LENGTH QUIX HWC NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention