BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEIDBRINK ROOT TIP PICK

    MDR report key: 1081053 · Received July 18, 2008

    Report

    Report Number
    1416605-2008-00002
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 24, 2008
    Manufacturer
    HU-FRIEDY MANUFACTURING, INC.
    Product Code
    ELC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIMENSIONS AND ROCKWELL HARDNESS OF THE INSTRUMENT MET SPECIFICATION REQUIREMENTS. THERE WAS NO PRE-EXISTING CRACK, FATIGUE OR SURFACE CORROSION WHICH COULD HAVE CAUSED THE PREMATURE FAILURE OF THIS INSTRUMENT. THE REMAINING UNBROKEN SECTION OF THE WORKING END WAS SLIGHTLY BENT BACKWARDS AND DID NOT MATCH SPECIFICATIONS. IT IS THEREFORE LIKELY IN THIS CASE, THAT TOO MUCH FORCE WAS APPLIED TO THIS INSTRUMENT WHICH CAUSED THE INSTRUMENT TIP TO FRACTURE AND BREAK OFF. ADDITIONALLY, THE EHB3 WAS WELL BEYOND IT'S 4 YEAR LIFE EXPECTANCY, WITH A MANUFACTURE DATE OF JUNE 1994.

    Description of Event or Problem · 1

    DURING A DENTAL PROCEDURE TO REMOVE A WISDOM TOOTH, A HEIDBRINK ROOT TIP PICK BROKE APPROXIMATELY 2 MM FROM THE TIP OF THE INSTRUMENT. THE TIP WAS NOT RETRIEVABLE DURING THE PROCEDURE AND WAS INADVERTEDLY PUSHED INTO THE MAXILLARY SINUS. THE PT WAS SENT TO AN ORAL SURGEON HAD A CALDWELL-LUC PROCEDURE WAS PERFORMED TO REMOVE THE TIP. THE PT WAS PUT ON ANTIBIOTIC THERAPY AND IS NOW RECOVERING WELL. HU-FRIEDY MANUFACTURING WAS MADE AWARE OF THIS INCIDENT ON 06/16/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEIDBRINK ROOT TIP PICK ROOT TIP PICK, SURGICAL, DENTAL ELC HU-FRIEDY MANUFACTURING, INC. EHB3 F7

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention