BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALL FLUTED 10BA30

    MDR report key: 797503 · Received December 5, 2006

    Report

    Report Number
    1625507-2006-00014
    Event Type
    Other
    Date Received
    December 5, 2006
    Date of Event
    November 6, 2006
    Report Date
    November 7, 2006
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: EVALUATON WAS NOT CONCLUSIVE, AS THE DEVICE WAS NOT RETURNED. DISSECTING TOOL BREAKAGE IS A KNOWN PROBLEM THAT MAY OCCUR DURING USE OF HIGH SPEED DISSECTING TOOLS. EXCESSIVE CUTTING FORCE OR BENDING OF TOOLS DURING USE CAN CAUSE BREAKAGE. WARNING IS PROVIDED IN DEVICE USER MANUAL INDICATING "DO NOT USE EXCESSIVE PRESSURE, SUCH AS BENDING OR PYRING, ON ATTACHMENTS OR DISSECTING TOOLS. THIS MAY CAUSE TOOL TO BEND OR BREAK AND CAUSE INJURY TO PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF." TOOLS RELEASED UNDER THIS LOT NUMBER WERE DISTRIBUTED ON ON BEFORE 11/06/2006. THERE HAVE BEEN NO REPORTS OF DISSECTING TOOL BREAKAGE FOR OTHER TOOLS FROM THIS LOT. IN THE PAST TWO YEARS. THERE HAVE BEEN NO ADDITIONAL REPORTS OF DISSECTING TOOL BREAKAGE FOR THESE TOOLS. THE CALCULATED INCIDENCE OF TOOL BREAKAGE FOR THIS TYPE IS 1/13798 OR 0.007%.

    Description of Event or Problem · 1

    DISSECTING TOOL BROKE DURING SPINAL INSTRUMENTATION PROCEDURE WHILE DRILLING PEDICLE. THE BROKEN PORTION OF THE TOOL WAS EMBEDDED IN THE BONE AND WAS LEFT IN THE PATIENT. NO ADDITIONAL ACTIONS WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. THE SURGEON IS EXPERIENCED IN THIS PROCEDURE AND CONSIDERED THE BREAKAGE UNUSUAL. HOSPITAL RISK MANAGEMENT IS HOLDING THE TOOL AND HAS INDICATED THAT PHOTOGRAPHS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALL FLUTED 10BA30 SURGICAL DISSECTING TOOL LEGEND HBE MEDTRONIC POWERED SURGICAL SOLUTIONS NA 5454L

    Patients

    Seq Age Sex Outcome Treatment
    1 *