BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DT UNIVERSAL DRILL

    MDR report key: 8434542 · Received March 19, 2019

    Report

    Report Number
    3001226627-2016-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Report Date
    March 19, 2019
    Manufacturer
    RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
    Product Code
    DZA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE 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. INVESTIGATION RESULTS RECEIVED: THE SEM INVESTIGATION DID NOT SHOW OR DETECT DEFECT IN THE MATERIAL. ACCORDING TO VDW, THE CUSTOMER FOLLOWED THE PROCEDURE BY USING A CANAL ROOT PREPARATION AND LOW SPEED AS RECOMMENDED 1000-200 PM. HOWEVER IN ABSENCE OF CLINICAL PROCEDURE DETAILS ASKED BY E-MAIL DATED ON (B)(6) 2016, IT IS DIFFICULT TO DETERMINE THE EXACT REASON. THE DARK/BACK AT THE BROKEN PART MAY SUGGEST TO THINK THAT THE DRILL WAS BLOCKED (FOR UNDETERMINED REASON) WHEN DURING THE DRILLING OPERATION. THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF RTD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DT UNIVERSAL DRILL BROKE DURING USE. THE BROKEN PART WAS RETRIEVED AND NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225530 DT UNIVERSAL DRILL DRILL, DENTAL, INTRAORAL DZA RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1