BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALL DIAMOND 10BA50DC

    MDR report key: 901335 · Received October 20, 2006

    Report

    Report Number
    1625507-2006-00012
    Event Type
    Other
    Date Received
    October 20, 2006
    Date of Event
    June 13, 2006
    Report Date
    June 16, 2006
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: REPORT WAS CONFIRMED BY DEVICE EVALUATION. THE SEPARATION OF THE BALL HEAD FROM THE TOOL SHAFT WAS CAUSED BY TORSIONAL OVERSTRESS FRACTURE. UPON INSPECTION OF THE TOOL SHAFT, IT WAS DETERMINED THAT THE STEM DIAMETER AT THE POINT OF BREAKAGE WAS BELOW THE MINIMUM SPECIFICATION. THIS PARAMETER IS INSPECTED ON A SAMPLE BASIS PRIOR TO LOT RELEASE. THE DEVICE HISTORY RECORD FOR THIS TOOL LOT WAS COMPLETE AND HAD NO NONCONFORMANCES. FORTY-SIX TOOLS WERE MANUFACTURED AND DISTRIBUTED UNDER THIS LOT NUMBER. THERE HAVE BEEN NO ADDITIONAL REPORTS OF TOOL BREAKAGE FOR OTHER TOOLS FROM THIS LOT. SPECIFIC WARNINGS ARE PROVIDED IN THE DEVICE USER MANUAL, "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." WHILE NO PATIENT INJURY WAS ASSOCIATED WITH THIS EVENT, THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY TO OCCUR IF THE EVENT WERE TO REOCCURR.

    Description of Event or Problem · 1

    "TOOL BROKE DURING USE." NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THE INITIAL REPORT. ON FOLLOW UP, IT WAS REPORTED THAT THE BROKEN PIECE DID NOT CONTACT THE PATIENT WOUND SITE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALL DIAMOND 10BA50DC SURGICAL DISSECTING TOOL LEGEND HBE MEDTRONIC POWERED SURGICAL SOLUTIONS NA 1291K

    Patients

    Seq Age Sex Outcome Treatment
    1 YR