BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAPERED F1/8TA15

    MDR report key: 668671 · Received September 12, 2005

    Report

    Report Number
    1625507-2005-00065
    Event Type
    Other
    Date Received
    September 12, 2005
    Date of Event
    July 5, 2005
    Report Date
    August 11, 2005
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "WHILE DRILLING FOR A BONE FLAP THE MIDAS REX DRILL BIT BROKE. ALL PIECES WERE RETRIEVED. THE EVENT REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM." INFO RECEIVED IN LETTER FROM THE HOSP. REPORT ORIGINALLY REPORTED BY SALES REP STATING THE LETTER WOULD PROVIDE FURTHER DETAILS. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED F1/8TA15 SURGICAL DISSECTING TOOL HBE MEDTRONIC POWERED SURGICAL SOLUTIONS * 2555F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention