BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY HEIDBRINK ROOT TIP PICK

    MDR report key: 1960040 · Received January 4, 2011

    Report

    Report Number
    1416605-2010-00004
    Event Type
    Other
    Date Received
    January 4, 2011
    Date of Event
    November 8, 2010
    Report Date
    December 17, 2010
    Manufacturer
    HU-FRIEDY MFG. CO., LLC.
    Product Code
    ELC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    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 MANUFACTURE. AT THE TIME OF MANUFACTURE, INSTRUMENTS WERE ONLY BEING MARKED WITH THE YEAR OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT WAS A (B)(4) INSTRUMENT THAT DOES NOT HAVE A EXP DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE RETURNED EHB3 HEIDBRINK ROOT TIP PICK HAS THE TIP BROKEN 5.85 MM FROM THE TIP. DIMENSIONAL AND HARDNESS ANALYSIS DETERMINED THAT THE INSTRUMENT MEETS ITS SPECS. THE INSTRUMENT APPEARS TO BE OLD AND WORN, THE UNBROKEN END IS HEAVILY NICKED AND SCRATCHED, WHICH CAN ACCUMULATE OVER TIME AND SERVE AS INITIATION SITES FOR FATIGUE FAILURES. THIS IS EVIDENCED BY THE OXIDIZED SURFACE ON THE RETURNED INSTRUMENT. THE RETURNED INSTRUMENT HAS THE SATIN HANDLE EXCESSIVELY SMOOTH, THIS IS AN INDICATION OF HEAVY USAGE. IN ADDITION THE LIFE EXPECTANCY OF THE RETURNED INSTRUMENT IS UP TO 7 YEARS, THE RETURNED INSTRUMENT WAS MANUFACTURED IN MAY 1998, WHICH MAKES THIS INSTRUMENT 5 YEARS BEYOND IT'S LIFE EXPECTANCY.

    Description of Event or Problem · 1

    DURING THE EXTRACTION OF TOOTH NUMBER 28, THE CROWN WAS FRACTURED, TO EXTRACT THE REMAINING ROOT, A STRAIGHT ELEVATOR AND APICAL ELEVATORS WERE USED. THE REMAINING ROOT WAS EXTRACTED IN ITS ENTIRETY. AFTER THE PROCEDURE FINISHED, THE INSTRUMENTS WERE PREPARED FOR THEIR STERILIZATION, THE HYGIENIST REPORTED THE BREAK OF AN INSTRUMENT, BEING THIS ONE OF THE APICAL ELEVATORS, THE SEARCH FOR THE BROKEN PIECE INSIDE THE FILTERS AND WASTE WAS NOT SUCCESSFUL. THE PT'S VISIT TO REMOVE THE SUTURES WAS USED TO TAKE A PANORAMIC X-RAY WHICH SHOWED THAT THE BROKEN PIECE OF THE INSTRUMENT IS WITHIN THE PT'S MAXILLARY SINUS. PT IS CONSULTING MULTIPLE MAXILLOFACIAL SURGEONS TO DETERMINE THE CONVENIENCE OF REMOVING THE BROKEN PIECE OF HER MAXILLARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY HEIDBRINK ROOT TIP PICK EHB3 ELC HU-FRIEDY MFG. CO., LLC. EHB3 E8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other