BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATRIX EXTRA SHAFT ASSY

    MDR report key: 16853982 · Received May 2, 2023

    Report

    Report Number
    2515379-2023-00073
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Report Date
    July 11, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D0026630161
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR 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.

    Additional Manufacturer Narrative · 0

    6-29-2023: PRODUCT NOT RETURNED, HOWEVER IMAGE ATTACHED DEPICTS AN AUTOMATE III HANDLE ASSEMBLY WITH FLEXSHAFT INSTALLED (DATE CODE COULD NOT BE VERIFIED WITH IMAGE) WITH COIL DEFORMATION CAUSED BY WELD FAILURE RENDERING THE PRODUCT UNUSABLE. CAPA-2021-375 OPENED TO ADDRESS WELD FAILURES, COIL/SPRING TEARS/DEFORMATION AND ¿BROKEN TIP¿ FOR PRODUCT MANUFACTURED BY SARASOTA SINCE DECEMBER 2020 (DATE CODE 1220) THROUGH IMPLEMENTATION DATE OF (B)(6) 2022 (0822). BATCH 04961585 OF ITEM# (B)(4) UTILIZED FLEXSHAFT ASSEMBLY ITEM (B)(4) BATCH 04908247 WHICH WAS PRODUCED IN OCTOBER 2021 (DATE CODE 1021). (NWV) 7-3-2023: SEE ATTACHMENT WORD DOCUMENT FOR DHR REVIEW AND RETAIN EVALUATION (LIMITED TO 1000 CHARACTERS ONLY IN THIS TEXT FIELD). (NWV).

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE IN PATIENT'S MOUTH DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247005 AUTOMATRIX EXTRA SHAFT ASSY INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 663016 04961585 D0026630161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown