BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE LANCE DRILL Ø1.5 MM

    MDR report key: 7572035 · Received June 5, 2018

    Report

    Report Number
    3011649314-2018-00172
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    March 22, 2018
    Report Date
    September 4, 2018
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED; HOWEVER, THE PATIENT'S NATIONALITY IS (B)(6). THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS LOST BY CUSTOMER. ONCE THE DEVICE'S EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE REPORTED LANCE DRILL IS PART OF INCLUSIVE TAPERED IMPLANT SURGICAL INSTRUMENTATION KIT (LOT # 6032603), WHICH WAS ASSEMBLED ON DECEMBER 2016.

    Additional Manufacturer Narrative · 1

    (EVENT 2 OF 3): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS REPORTED TO BE "LOST" BY THE DENTIST. A LOT NUMBER WAS RECEIVED AND A DEVICE HISTORY RECORD REVIEW (DHR) WAS CONDUCTED. THERE WAS NO EVIDENCE TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE REPORTED ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE RECEIVING INSPECTION ROUTER. ALTHOUGH THE ROOT CAUSE COULD NOT BE EXPLICITLY DETERMINED, A POSSIBLE CAUSE FOR THE REPORTED ISSUE COULD BE EXCESSIVE LATERAL FORCE WAS APPLIED DURING THE PROCEDURE. THE EXCESSIVE FORCE COULD HAVE CAUSED THE BREAKAGE OF THE DRILL AT THE PORTION BETWEEN THE SHANK AND THE CUTTING PART. ANOTHER POSSIBLE ROOT CAUSE COULD BE IMPROPER POSITIONING OF THE LANCE DRILL DURING OSTEOTOMY PREPARATION. PER PROVIDED INFORMATION, THE DENTIST USED THE LANCE DRILL ABOUT 7 TIMES BEFORE THE LANCE DRILL BROKE. PER RECOMMENDATION IN THE INCLUSIVE DENTAL IMPLANT SYSTEM SURGICAL MANUAL, IT STATED THAT "...DRILLS MAY BE USED FOR UP TO FIVE PREPARATIONS, DEPENDING ON BONE DENSITY. FOR BEST RESULTS, REPLACE REGULARLY." ADDITIONALLY, THE INCLUSIVE DENTAL IMPLANT SYSTEM IFU RECOMMENDED THAT ". ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR NECROSIS OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO. SINCE IMPLANT COMPONENTS AND THEIR INSTRUMENTS ARE VERY SMALL, PRECAUTIONS SHOULD BE TAKEN TO ENSURE THAT THEY ARE NOT SWALLOWED OR ASPIRATED BY THE PATIENT. PRIOR TO SURGERY, ENSURE THAT THE NEEDED COMPONENTS, INSTRUMENTS AND ANCILLARY MATERIALS ARE COMPLETE, FUNCTIONAL AND AVAILABLE IN THE CORRECT QUANTITIES." THE ACTUAL DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, A SAME DEVICE FROM THE SAME LOT NUMBER WAS RETURNED AND HAD BEEN INVESTIGATED. IT WAS FOUND THAT THE DEVICE HAD NO MANUFACTURING DEFECT NOR DESIGN ISSUE; THEREFORE, THIS EVENT WAS A RANDOM COMPONENT FAILURE. THIS EVENT WILL BE MONITORED, TRACK AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LANCE DRILL (INCLUSIVE SURGICAL SYSTEM) WAS BROKEN DURING THE PROCEDURE. THE DRILL WAS USED ABOUT 7 TIMES BEFORE IT WAS BROKEN. THE DRILL WAS USED WITH W&H HANDPIECE. THE DENTIST WAS OPERATING THE DRILL IN THE 800 RPM RANGE. RUBBER DAM WAS NOT USED DURING THE PROCEDURE. THE DRILL WAS CLEANED REGULARLY AFTER USE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411972 INCLUSIVE LANCE DRILL Ø1.5 MM INCLUSIVE LANCE DRILL Ø1.5 MM NDP PRISMATIK DENTALCRAFT, INC. 70-1071-SRG0030 6006233

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR