BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON MICRO CURETTE ANG 1X2MM CUP 7-1/2

    MDR report key: 2261031 · Received September 23, 2011

    Report

    Report Number
    1923569-2011-00008
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FZS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION MEDICAL DEVICE COMPLAINTS WERE PREVIOUSLY MANAGED BY CARDINAL HEALTH UNDER A TRANSITIONAL SERVICE AGREEMENT FROM SEPT 1, 2009 TO JULY 7, 2011. IN RETROSPECTIVE REVIEW BY CAREFUSION REPRESENTATIVES IT WAS DETERMINED THAT THIS EVEN NECESSITATES SUBMISSION AS AN MDR IN ADHERENCE WITH 21 CODE OF FEDERAL REGULATION PART 803. NO INSTRUMENT WAS RECEIVED FOR EVALUATION. THE LOT CODE CANNOT BE DETERMINED WITHOUT SAMPLE, AND NO LOT CODE WAS REPORTED. THE CURRENT LOT (AT THE TIME OF THE REPORT) DEVICE HISTORY RECORD WAS REVIEWED, WITH NO ISSUES FOUND. COMPLAINT TRENDING ANALYSIS PERFORMED. NO TREND OR ISSUES WERE FOUND FOR THIS TYPE OF COMPLAINT ON THIS PRODUCT CODE. WITHOUT THE ACTUAL SAMPLE, THE REPORT CANNOT BE CONFIRMED NOR COULD A ROOT CAUSE BE ASSIGNED. NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A CERVICAL DISK SURGERY, RHOTON DISSECTOR (MICROCURETTE) BROKE OFF BUT THE FRAGMENT WAS LOCATED BY THE NEUROSURGEON AND REMOVED. THE ORIGINAL INTENDED PROCEDURE WAS AN ANTERIOR CERVICAL DISK FUSION WITH ALLOGRAFT. THE FOLLOWING IS ADDITIONAL INFORMATION OBTAINED ON (B)(4) 2011: THE PATIENT'S ORIGINAL DIAGNOSIS WAS CERVICAL DISCOGENIC DISEASE C2-3 (L) AND C 6-7 (L). THE CASE WAS NOT DELAYED. THE RETRIEVAL OF THE INSTRUMENT PART WAS STRAIGHT FORWARD AND IMMEDIATE AND NO ADDITIONAL ANESTHESIA, SURGICAL, OR MEDICAL INTERVENTION WAS REQUIRED. THE PIECE FELL INTO THE INCISION BUT WAS REMOVED EASILY USING INSTRUMENTATION AT HAND. THE INSTRUMENT WAS THEN SET ASIDE. OTHER INSTRUMENTS IN THE SET WERE USED IN ITS PLACE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHOTON MICRO CURETTE ANG 1X2MM CUP 7-1/2 CURETTE, SURGICAL, GENERAL USE FZS CAREFUSION NL3785-014

    Patients

    Seq Age Sex Outcome Treatment
    1