BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY #2 MOLT SINGLE END CURETTE

    MDR report key: 2306028 · Received October 11, 2011

    Report

    Report Number
    1416605-2011-00003
    Event Type
    Other
    Date Received
    October 11, 2011
    Date of Event
    August 3, 2011
    Report Date
    October 7, 2011
    Manufacturer
    HU-FRIEDY MFG. CO.,INC.
    Product Code
    EKE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT OF PT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE THE INFO. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT # WHICH IS TIED TO THE DATE OF MFR. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE A EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. RETURNED TIP IS BROKEN APPROX 11.4 MM FROM THE TIP. BROKEN TIP WAS INCLUDED. RETURNED INSTRUMENT IS OLD AND WORN. THE BROKEN TIP IS DAMAGED. IT IS DULL, CHIPPED, AND HAS GOUGES AT THE BACK OF THE WORKING END. THE REMAINING UNBROKEN SECTION (SHANK) IS BENT AND DOES NOT MATCH CURRENT PRODUCT. CONCLUSION: BREAKAGE APPEARS TO HAVE BEEN THE RESULT OF APPLYING A FORCE HIGHER THAN MATERIAL CAPABILITY TO THE WORKING END. THESE TYPES OF INSTRUMENTS (CM2) HAVE A NORMAL LIFE EXPECTANCY OF UP TO 4 YEARS. THE RETURNED INSTRUMENT WAS MFG ALMOST 26 YEARS AGO (1985).

    Description of Event or Problem · 1

    THE CURETTE WAS BEING USED TO EXTRACT A MAXILLARY MOLAR. THE END OF CURETTE FRACTURED WHILE REMOVING THE REMAINING DISTAL ROOT TIP. THE TIP FELL INTO THE MAXILLARY SINUS CAVITY THROUGH THE ORAL ANTRAL OPENING THAT WAS CREATED BY THE EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY #2 MOLT SINGLE END CURETTE CM2 EKE HU-FRIEDY MFG. CO.,INC. CM2 1985

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other