BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 2971511 · Received June 27, 2007

    Report

    Report Number
    2971511
    Event Type
    Malfunction
    Date Received
    June 27, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 14, 2007
    Manufacturer
    MEDTRONIC INC, POWERED SURGICAL SOLUTION
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF DRILL BIT BROKE OFF DURING USE, WAS REMOVED CLEANED AND AVAILABLE FOR MEDWATCH. NO APPARENT DAMAGE TO PT. NOT SURE IF TIP DEFECTIVE BUT REMOVED ALL DRILL BITS FROM INVENTORY/STOCK IN LOT #2529N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC LEGEND DISSECTION TOOL T12 HBE MEDTRONIC INC, POWERED SURGICAL SOLUTION 2529N

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR