BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER RONGEUR'S - METREX

    MDR report key: 2180606 · Received July 12, 2011

    Report

    Report Number
    2180606
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    RECENTLY, WHILE SERVICING THE METREX SPINE SETS AT SEVERAL OTHER HOSPITALS IN THE AREA, WE HAVE NOTICED AN INORDINATE AMOUNT OF DECKER RONGEUR'S THAT HAVE FRACTURES AT THE FRONT JAW PIVOT PINS. WE USUALLY FIND 2 TO 3 OF THESE INSTRUMENTS WITH PIVOT HOUSING FRACTURES. THESE USUALLY APPEAR AS MICRO FRACTURE LINES AT THE PIVOT HOUSING WITH RUST & CORROSION STAINS ON THE BORDERS OF THE FRACTURES. THE CAUSE OF THESE FRACTURES COULD BE AS FOLLOWS: (1) A FAULTY SERIES OF MANUFACTURED PRODUCT. (2) BITING OR TWISTING THE RONGEUR CAUSING OVER MECHANICAL STRESSING OF THE PIVOT PIN HOUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECKER RONGEUR'S - METREX SPINE SETS - DECKER RONGEUR'S HTX MEDTRONIC 9569567, 9569565, 9569536 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES