BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2 NITI TAPER .05 STERILE WP16

    MDR report key: 14307541 · Received May 6, 2022

    Report

    Report Number
    9611053-2022-00543
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Report Date
    May 9, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO INJURY WAS REPORTED, 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. THE RETURNED MTWO UNIFILE R25 5/100 25MM 015 IS BROKEN AT THE TIP OF THE ACTIVE PART (MIXED CONDITIONS TORQUE + FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1739467, #1740511, #1741643 AND #1739632). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Additional Manufacturer Narrative · 0

    THE RETURNED MTWO UNIFILE R25 5/100 25MM 015 IS BROKEN AT THE TIP OF THE ACTIVE PART (MIXED CONDITIONS TORQUE + FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1739467, #1740511, #1741643 AND #1739632). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND 1) PRODUCT VISUAL IDENTIFICATION AND LIABILITY WITH THE COMPLAINT (REFERENCE, DRAWING REVISION, QUANTITY). PASS. M2 NITI TAPER .05 STERILE WP16. 2)VISUAL INSPECTION "ANALYSIS ACCORDING TO F801.223. REFERENCE DOCUMENT: LABORATORY REPORT 12-HO-003." PASS. INSTRUMENT LOCALLY BENT AT 1MM FROM THE TIP/15°. FLUTES WITH REWINDING ON 0.25-1.5MM FROM THE TIP. CUTTING EDGES WITH CRACKS WITHOUT STEP. SHAFT WITHOUT DAMAGE. HANDLE WITHOUT DAMAGE. FLAT BREAKING PATTERN PERIMETER, WITH PERPENDICULAR SURFACE WITHOUT STEPS FOLLOWING THE GRINDING GROOVES AT 0.25MM FROM THE TIP. ROTATIONAL MARKS OF CONTACT ON ALMOST ALL THE SURFACE. MATERIAL WITHOUT VISIBLE DEFECT. RUPTURED INSTRUMENT UNDER MIX CONDITIONS: TORQUE, FATIGUE AND THEN RUPTURE UNDER SMALL TORQUE (MODEFT1), WHILE PUSHING INTO A ROOT CANAL STRAIGHT PORTION. 3)DIMENSIONAL CHECKING N/A. 4)MECHANICAL RESISTANCE / DIMENSIONAL INSPECTION "MEASURING CONDITIONS AND SAMPLING ACCORDING TO ISO 3630-1 " NOT POSSIBLE NO UNUSED FILE RETURNED. 5)MECHANICAL RESISTANCE / MECHANICAL RESISTANCE TEST "TESTING CONDITIONS AND SAMPLING ACCORDING TO ISO 3630-1 " NOT POSSIBLE NO UNUSED FILE RETURNED. 6)FUNCTIONAL TEST N/A . 7)CUTTING TEST N/A N/A 8)GENERAL COMMENTS PASS A3;1MM FROM THE TIP/15°;B3;0.25-1.5MM FROM THE TIP;C5;D0;E0;F1;0.25MM FROM THE TIP;G1;H0.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A MTWO FILE BROKE DURING USE. BROKEN PIECE REMAINED IN CANAL AND WAS INCORPORATED INTO THE FILLING. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976043 M2 NITI TAPER .05 STERILE WP16 FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 378373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown