BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER H-U 19MM/SX *NOT CE*

    MDR report key: 22142520 · Received June 4, 2025

    Report

    Report Number
    8031010-2025-00090
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 14, 2025
    Report Date
    June 24, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D716PTUHSX191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1770975). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE (HAND USED FILE - TECHNIQUE NO MORE VERIFIABLE TO DATE), OVERUSE (NUMBER OF USES NOT COMMUNICATED), EXCESSIVE WEAR, PATIENT CONDITION AND BEHAVIOR DURING TREATMENT OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). IN ADDITION, THERE ARE FURTHER CIRCUMSTANCES ON THE CONDITIONS IN DENTISTRY (USED DISINFECTANTS, TRAINING/KNOWLEDGE STATUS), OR ANY OTHER ENVIRONMENTAL CONDITIONS, WHICH ARE UNKNOWN TO US AND MAY ALSO HAVE AN IMPACT ON THE REPORTED FAILURE MODE. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO INJURY. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - IMPACT CODE - 4648. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - IMPACT CODE - 2199. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PROTAPER H-U 19 MM/SX *NOT CE* FILE BROKE DURING USE. THE INSTRUMENT SEPARATED AND ABOUT 15 MM OF BROKEN TIP WAS LEFT IN THE CANAL. THE NEXT DAY THE PATIENT WAS SEEN AT SPECIALIST HOSPITAL TO REMOVE THE BROKEN PART UNDER MICROSCOPE. THE OUTCOME OF THE EVENT I NOT KNOWN AS OF THIS MDR, FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822053 PROTAPER H-U 19MM/SX *NOT CE* FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1770975 D716PTUHSX191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown