BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 4503899 · Received February 9, 2015

    Report

    Report Number
    3005180920-2015-00013
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO RECEIVED ON 01/29/2015 BY MEDACTA PEOPLE THAT WERE IN THE THEATRE: THE TIP OF THE SCREWDRIVER, WHICH INTERFACES WITH THE SCREW, HAS SEVERAL FLANGES OF WHICH SOME BROKE OFF. FRAGMENT WAS REMOVED FROM THE PT. THE FINAL X-RAY WAS USED TO CONFIRM AMONG OTHERS THAT NO FRAGMENT REMAINED INSIDE. THERE WAS MINIMAL AMOUNT OF DELAY, TALKING ABOUT 5 MINUTES ON A 4 HR SURGERY (2 LEVEL REVISION ACDF). THE BREAKAGE OF THE PIECE IS LIKELY TO BE ASSOCIATED TO A USER ERROR BY THE SURGEON. ON 02/04/2015, R&D DIRECTOR OF SPINE REVIEWED THE X-RAYS RECEIVED: THE X-RAY DOESN'T SHOW ANY FRAGMENT OF THE INSTRUMENT. I WAS PRESENT DURING THE CASE AND REVIEWED THE X-RAY TOGETHER WITH THE SURGEON. HE CONFIRMED THAT THERE ARE NO FRAGMENT OF THE INSTRUMENT LEFT IN THE PT. ON THE X-RAY, YOU CAN SEE THE CERVICAL PLATE WITH THE SCREWS INSIDE. IN ADDITION, YOU CAN SEE SEVERAL PINS WHICH ARE THE TANTALUM MARKERS OF THE TWO CERVICAL CAGES. EACH CAGE HAS 4 PINS. THEREFORE, WE SEE A TOTAL OF 8 PINS. THERE IS NO STST SEGMENT VISUAL ON THE X-RAY. STST IS CLEARLY DETECTABLE ON AN X-RAY AND WOULD APPEAR IN SIMILAR COLOUR AS THE WELL VISIBLE MARKERS OF THE CAGE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89791 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH

    Patients

    Seq Age Sex Outcome Treatment
    1