BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP SATELEC INSERT 3

    MDR report key: 24380216 · Received February 18, 2026

    Report

    Report Number
    8031010-2026-00017
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Report Date
    March 26, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: WE RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT : GENERATOR WHICH HAS BEEN USED AND POWER LEVEL? DTE, LEVEL 7. HAS ANY PATIENT BEEN INJURED? NO. HAVE ALL THE BROKEN PARTS BEEN RETRIEVED FROM PATIENT¿S MOUTH? YES. HAS ANY FURTHER MEDICAL OR SURGICAL TREATMENT BEEN NECESSARY AFTER THE EVENT? NO. HOW MANY TIMES HAS THE INSTRUMENT BEEN USED BEFORE THE EVENT HAPPENED? 2. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. INVESTIGATION RESULTS: ATTENTE PRODUIT. START-X TIP SATELEC INSERT 3 LOT#1920345. DENTSPLY SIRONA BENSHEIM REPORTED THAT THERE WAS "FRACTURED TIP". THE BATCH NUMBER IS KNOWN, CERTIFICATE OF CONFORMITY IS AVAILABLE. NO RELEVANT INFORMATION WAS FOUND DURING DHR REVIEW (NO NONCONFORMING MATERIAL REPORT WAS ISSUED DURING MANUFACTURING OR PACKAGING PROCESSES). PLEASE NOTE THAT THIS PRODUCTION WAS MADE UNDER THE PROCESS DEVIATION SI 1047, ISSUED TO ADD A CONTROL OF THE RUNOUT ON SOME RAW MATERIAL BARS WHICH MIGHT HAVE BEEN DAMAGED DURING TRANSPORT. NO RELATION WITH THE SUBJECT OF THE COMPLAINT. THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE RETURNED START-X TIP SATELEC INSERT 3 IS BROKEN IN THE MIDDLE OF THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED DEVICE IS AVAILABLE FOR EVENTUAL EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1920345). WE CANNOT RULE ON THE COMPLIANCE OF THE POWER SETTINGS SELECTED BY THE CUSTOMER IN COMPARISON WITH THE ONES RECOMMENDED BY MAILLEFER WHICH ARE EXCLUSIVELY GIVEN FOR SATELEC GENERATORS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. GENERALLY SPEAKING, SEVERAL OTHER FACTORS MAY CONTRIBUTE TO BREAKAGE ISSUE, SUCH AS USURY, PRESSURE OR INCORRECT TECHNIQUE. ALL OF THESE FACTORS MAY AFFECT THE LONGEVITY OF THE TIP. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE: 4580. HEALTH EFFECT - IMPACT CODE: 4648. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE: 4582. HEALTH EFFECT - IMPACT CODE: 2199. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    Additional Manufacturer Narrative · 0

    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED 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 START-X TIP SATELEC INSERT 3 TIP 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
    349308 START-X TIP SATELEC INSERT 3 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1920345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown