BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM

    MDR report key: 6031569 · Received October 14, 2016

    Report

    Report Number
    2320721-2016-00055
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    January 18, 2017
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    DZM
    PMA / PMN Number
    K990511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THIS REPORT IS FOR THE SECOND DEVICE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED 50 UNOPENED DRILL AND GUIDE SLEEVES FOR LOT NUMBER 115742 AND 6 UNOPENED DRILL AND GUIDE SLEEVES FROM PREVIOUS LOT NUMBER THAT HAD EXPIRED ON 05 2015. NO BENT, BROKEN, OR OPENED PRODUCT WAS RETURNED. UNKNOWN WHICH LOT CUSTOMER WAS REFERRING TO IN THE COMPLAINT. NO TESTING PERFORMED ON EXPIRED PRODUCT. USING THE (B)(4) PLAN WITH AND AQL OF 1.5 USING NORMAL SAMPLE PLAN RANDOMLY SELECTED AND TESTED 8 PIECES FROM THE LOT NUMBER WITH NON EXPIRED PRODUCT. USING MICROSCOPE VISUALLY CHECKED DRILLS. NO MANUFACTURING DEFECTS OR MARKINGS NOTED ON DRILLS. USING TEST METHOD (B)(4) FOR THE GO RING GAUGE. ALL 8 TESTED PASSED THE THROUGH THE GO RING GAUGE. TESTED DRILLS USING A PUSH BUTTON CONTRA ANGLE AND DRILLS FIT INTO THE CONTRA ANGLE WITH NO HESITATION. NO FAULT FOUND WITH RETURNED DRILLS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE X-TIPS BROKE DURING USE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682071 X-TIP INTRAOSSEOUS ANESTHESIA DELIVERY SYSTEM NEEDLE, DENTAL DZM DENTSPLY TULSA DENTAL SPECIALTIES NA 0000115742

    Patients

    Seq Age Sex Outcome Treatment
    1