BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY EXPRO

    MDR report key: 2496662 · Received March 16, 2012

    Report

    Report Number
    1416605-2012-00001
    Event Type
    Other
    Date Received
    March 16, 2012
    Report Date
    March 9, 2012
    Product Code
    EIX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT IS BROKEN NEAR THE 3 MM MARKING. FRACTURE SURFACE SHOWS NO SIGNS OF CORROSION. BOTH WORKING END S OF THE RETURNED INSTRUMENT ARE BENT AND DO NOT MATCH HU-FRIEDY MASTER SAMPLE IN SHAPE. RETURNED EXPO WAS VISUALLY INSPECTED UNDER MAGNIFICATION (20X) AND THE REMAINING SECTION OF THE PROBE END AND THE EXPLORER WORKING END WERE FOUND TO HAVE DEEP NICKS AND SCRATCHES. THE DEEP NICKS AND SCRATCHES ARE INDICATION OF THE TIPS GETTING CAUGHT IN THE HOLES OF AN ULTRASONIC CLEANER BASKET/TRAY OVER TIME. THIS CAUSES TIPS TO BEND AND IF WORKING END ARE RE-SHAPED, THIS TYPE OF MOVEMENT CAN LEAD TO LOW CYCLE FATIGUE WHEREBY A FORCE HIGHER THAN MATERIAL CAPABILITY CAN LEAD TO BREAKAGE OF THE TIP. ADDITIONALLY, THESE TYPES OF INSTRUMENTS (XPC44757C) HAVE A NORMAL LIFE EXPECTANCY OF UP TO 4 YRS. THE RETURNED INSTRUMENT WAS MANUFACTURED OVER 5 YRS AGO (AUG. 2006).

    Description of Event or Problem · 1

    DURING THE COURSE OF A ROOT CANAL PROCEDURE, A DOCTOR WAS USING A HU-FRIEDY PROBE TO MEASURE A CANAL ABSCESS. THE FOLLOWING WEEK, THE PT RETURNED TO THE DOCTOR FOR A F/U AND THE DOCTOR NOTICED THAT A SMALL PIECE OF THE TIP OF THE PROBE WAS EMBEDDED IN THE PT'S TISSUE. THE DOCTOR INFORMED THE PT AND INDICATED THAT HE WOULD NEED TO MAKE A SMALL SURGICAL INCISION TO REMOVE THE EMBEDDED TIP. THE DOCTOR PROCEEDED TO REMOVE THE TIP AND THE SURGICAL SITE HEALED W/O ANY FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY EXPRO XPC44757C EIX XPC44757C V6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other