BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 5038652 · Received August 28, 2015

    Report

    Report Number
    3005180920-2015-00182
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    July 30, 2015
    Report Date
    November 26, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 27 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 10 NOVEMBER 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    THE 5 SIMILAR CASES HAVE BEEN REPORTED UNDER MDRS # 2015-00013; 2015-00015; 2015-00019; 2015-00111; 2015-00133. THE R&D PROJECT MANAGER ANALYZED THE RETRIEVED ITEMS (2 OF THE SAME LOT) ON 25 AUGUST 2015, WITH THE FOLLOWING COMMENT: DURING THE ANALYSIS WAS NOTED THAT THE PRONGS WERE BROKEN IN THE SAME FASHION AS THE PREVIOUS ONES. IN ORDER TO ADDRESS PARTICULAR SCLEROTIC BONE CONDITION, ADDITIONAL INSTRUMENT THAT ALLOW TO PRE-TAP THE PILOT HOLE HAVE BEEN DEVELOPED. ADDITIONALLY, THE SCREWDRIVER DESIGN HAS BEEN REVIEWED TO ADDRESS SUCH EXTREME BONE CONDITION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE - SPINE CERVICAL PLATE POSITION - THE SURGEON WAS PLACING THE SCREWS AS PER STANDARD SURGICAL TECHNIQUE, AND UNDER THE VISION OF THE MICROSCOPE. WHILE HE WAS PLACING THE 4TH AND FINAL SCREW, HE DISENGAGED THE SLEEVE OF THE SCREWDRIVER OFF THE SCREW BECAUSE HE WANTED BETTER VISUALISATION OF THE TIP OF THE SCREWDRIVER ONTO THE TIP OF THE SCREW. DUE TO THE PATIENT'S BONE VERY SCLEROTIC, HE WAS FINDING IT TOUGH TO ADVANCE THE SCREW AND HAD TO EXERT MORE FORCE WHILE TURNING THE HANDLE. DURING THE PROCESS THE SCREWDRIVER SNAPPED, BREAKING 3 OF THE 4 PRONGS. WE THEN GOT THE 2ND SCREWDRIVER OUT OF THE SET AND CONTINUE TO ADVANCE THE SCREW AND AS THE SCREW WAS FULLY SEATED INTO THE CERVICAL PLATE, THE SAME THING OCCURED WITH 3 OF THE 4 PRONGS BREAKING. IT WAS FORTUNATE THAT AT THIS STAGE ALL 4 SCREWS HAD BEEN FULLY SEATED AND WE WERE ABLE TO COMPLETE FINAL TIGHTENING AND FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573260 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1316455

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other