BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND TAPERED DISSECTING TOOL

    MDR report key: 2962361 · Received February 14, 2013

    Report

    Report Number
    1625507-2013-00011
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE CONDITION OF THE TIP EDGES INDICATES THAT THE TOOL WAS NOT PUSHED HARD ENOUGH TO CONTACT LEG OF THE AF02 WHILE ROTATING. EXTENSIVE CUT TESTING WITH THE F2/8TA23S BURS INDICATES THAT THIS TOOL CANNOT SUSTAIN THE SAME CUTTING PRESSURE AS A NON - SPIRAL F2 TOOL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISSECTING TOOL BROKE DURING A SURGICAL PROCEDURE ON (B)(6) 2013. THE SURGEON WAS TURNING HIS CRANIAL FLAP AND THE SPONGE WRAPPED AROUND THE TOOL AND CREATED A LOT OF TORQUE ON THE TOOL. IT TOOK HIM AWHILE TO GET THE SPONGE OFF OF THE TOOL. HE CONTINUED TO TURN HIS FLAP AND REALIZED THE TOOL BROKE. WHEN THE SALES REP ASKED THE DOCTOR, THE DOCTOR DID NOT FEEL IT WAS THE FAULT OF THE DRILL OR THE DRILL BIT. BUT, IT WAS BECAUSE THE SPONGE WRAPPED AROUND THE DRILL AT SUCH A HIGH SPEED. THEY FOUND THE BROKEN TIP IN THE PATIENT'S SCALP. ALL PIECES WERE RECOVERED. OVERALL, THE PATIENT WAS NOT IMPACTED. IT IS NOT KNOWN IF THE PATIENT WAS UNDER THE AGE OF 21 OR NOT. INITIAL REPORTER AND PHYSICIAN'S NAME WAS ALSO PROVIDED. ON FOLLOW - UP IT WAS REPORTED THAT THERE WAS A SLIGHT DELAY FROM COMPLETING X-RAYS TO DETERMINE WHERE THE MISSING PIECES WERE. IT WAS CONFIRMED THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65943 LEGEND TAPERED DISSECTING TOOL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS N/A 0006285894

    Patients

    Seq Age Sex Outcome Treatment
    1