BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOOL LGD 12CM 2.5MM MATCH LG

    MDR report key: 1954600 · Received January 10, 2011

    Report

    Report Number
    1625507-2011-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 3, 2010
    Report Date
    January 25, 2011
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS DETERMINED TO BE A DUPLICATE OF AN EVENT THAT WAS ORIGINALLY REPORTED ON MEDWATCH 1625507-2010-00073. PLEASE SEE MEDWATCH 1625507-2010-00073 FOR COMPLETE INFORMATION.

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. NO EVALUATION WAS PERFORMED, AS THE PART WAS NOT RETURNED. IF THE PRODUCT IS RETURNED IN THE FUTURE, A COMPLAINT INVESTIGATION WILL COMMENCE. NO DEVIATIONS WERE NOTED IN THE DEVICE HISTORY. THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT/LOT NUMBER COMBINATION. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THE USER MANUAL CONTAINS THE FOLLOWING "DO NOT USE EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, ON ATTACHMENTS OR DISSECTING TOOLS. THIS MAY CAUSE TOOL TO BEND OR BREAK AND CAUSE INJURY TO PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REPORT RECEIVED STATING THAT "MEDTRONIC MIDAS REX T-12 DRILL BIT BROKE IN TWO PIECES DURING A NEUROSURGERY PROCEDURE. BOTH PIECES WERE RETRIEVED BY THE PHYSICIAN. THE BROKEN DRILL BIT WAS REMOVED FROM THE SURGICAL FIELD AND AN X-RAY WAS TAKEN PER THE PHYSICIAN'S ORDER. X-RAY WAS RETRIEVED BY THE PHYSICIAN AND NO RETAINED DRILL BIT FRAGMENTS WERE SEEN. DRILL BIT SHAFT BROKE ABOUT 2.5CM FROM THE BIT TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOOL LGD 12CM 2.5MM MATCH LG DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS N/A 0004541349

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR