BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDYNABERS PROBE WITH SATIN STEEL HANDLE

    MDR report key: 1378577 · Received May 8, 2009

    Report

    Report Number
    1416605-2009-00002
    Event Type
    Other
    Date Received
    May 8, 2009
    Date of Event
    March 30, 2009
    Report Date
    May 3, 2009
    Manufacturer
    HU-FRIEDY MFG, INC.
    Product Code
    EIX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A HU-FRIEDY REPRESENTATIVE RECEIVED AN E-MAIL FROM DR. (B)(6) WITH INFO RELATED TO AN ADVERSE EVENT CAUSED BY A HU-FRIEDY NABERS PROBE. THE EVENT OCCURRED ON (B)(6) 2009 AND INVOLVED A (B)(6) MALE, NO WEIGHT INFO WAS AVAILABLE. THE INSTRUMENT WAS RETURNED ON (B)(6) 2009 FOR EVAL BY QUALITY ASSURANCE. THE INSTRUMENT, WHICH WAS MANUFACTURED IN APRIL OF 2008, BROKE AT THE FIRST 3MM MARKING. VISUAL AND DIMENSIONAL INSPECTIONS REVEALED NO MANUFACTURING DEFECTS. UPON FOLLOW-UP CONVERSATION WITH THE DOCTOR, IT WAS DETERMINED THAT THE INSTRUMENTS, WHICH ARE THIN AND FRAGILE AT THE WORKING END, MAY BE GETTING CAUGHT IN THE WIRE MESH BASKET OF THE ULTRASONIC BATH USED FOR CLEANING OF THE INSTRUMENTS. THIS COULD LEAD TO EXCESSIVE STRESS ON THE INSTRUMENT, WHICH COUPLED WITH THE FORCE APPLIED DURING THE PROCEDURE EXCEEDED THE MATERIAL'S CAPABILITY AND CAUSED THE TIP TO FRACTURE. ADDITIONAL NOTES: THE PERIODONTIST'S OFFICE WAS NOT ABLE TO PROVIDE ANY WEIGHT INFO ON THE PT. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY (B)(4) DEVICES, BY SERIAL NUMBER, ONLY A LOT # WHICH IS TIED TO THE DATE OF MANUFACTURE. THE PRODUCT INVOLVED IN THE EVENT WAS (B)(6) THAT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE.

    Description of Event or Problem · 1

    DURING A ROUTINE PERIODONTAL EXAMINATION OF PT'S FURCATIONS, A HU-FRIEDY NABERS PROBE FRACTURED BELOW THE GINGIVAL MARGIN. THE TIP BECAME LODGED IN THE PT'S GINGIVAL TISSUE AND THE PERIODONTIST ENTERED THE SITE SURGICALLY TO REMOVE THE TIP. THE SURGICAL SITE WAS CLOSED WITH A NON-ABSORBABLE SUTURE. THE PT RETURNED TO THE PERIODONTIST'S OFFICE ON (B)(6) 2009 FOR REMOVAL OF THE SUTURE, NO COMPLICATIONS OCCURRED FROM THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDYNABERS PROBE WITH SATIN STEEL HANDLE EIX - PERIODONTIC PROBE EIX HU-FRIEDY MFG, INC. PQ2N7 R8

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other NO CONCOMITANT MEDICAL PRODUCTS WERE IN USE &| THERE ARE NO APPLICABLE THERAPY DATES