BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 3-FILE STER 21MM

    MDR report key: 18181107 · Received November 21, 2023

    Report

    Report Number
    8031010-2023-00873
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 21, 2023
    Report Date
    January 5, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D716WGPRIME211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT NOT ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH AND THERE IS FURTHER MEDICAL/SURGICAL TREATMENT PLANNED. THERE IS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED AFTER THE ABOVE INFORMATION THAT ADDITIONAL DENTAL TREATMENT OF RCT WAS DONE TO THE AFFECTED TOOTH WITH ANOTHER SET OF FILES. INVESTIGATION: SUMMARY: TWO WAVEONE GOLD PRIMARY FILES 25MM WERE RETURNED IN LOOSE. THE TWO FILES ARE BOTH BROKEN AT THE TIP OF THE ACTIVE PART (TORQUE OR FATIGUE + TORQUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1770506). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. FOR INFORMATION, WE NOTED THAT THE FILES HAS NO RED ABS RING. RINGS WERE VOLUNTARILY REMOVED (TOOL MARKS ARE VISIBLE IN THE EMPTY GROOVES). WE SUSPECT THE CUSTOMER TO HAVE REMOVED THE ABS RINGS TO BE ABLE TO REUSE THE FILES WHICH WOULD CONSTITUTE A MISUSE. INDEED, WAVEONE GOLD FILES ARE SINGLE USE INSTRUMENTS WHOSE ABS RING IS INTENDED TO PREVENT ANY REUSE BY EXPANDING IN CASE OF STERILIZATION OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089697 WAVEONE GOLD PRIMARY 3-FILE STER 21MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1770506 D716WGPRIME211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown