BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATE TOOL REFILL

    MDR report key: 21559093 · Received March 10, 2025

    Report

    Report Number
    2515379-2025-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    March 6, 2025
    Report Date
    May 6, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D0026631001
    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

    INVESTIGATION RESULT: RETURN. 5-5-2025: RETURNED PRODUCT 1 AUTOMATE III TIGHTENING DEVICE WITH A FLEXSHAFT ASSEMBLY DATE CODED 0924 WITHOUT ORIGINAL PACKAGING. THE FLEXSHAFT ASSEMBLY EXHIBITED EVIDENCE OF COIL DEFORMATION/WELD FAILURE RESULTING IN THE FLEXSHAFT ASSEMBLY TO NO LONGER FUNCTION PROPERLY. THE RETUNED AUTOMATE III TIGHTENING DEVICE WAS INSPECTED AND TESTED USING STANDARD TESTING PROTOCOL. THE TESTS INCLUDED A FUNCTIONAL TEST, WHICH IS TO USE THE TOOL TO TIGHTEN A MATRIX BAND AROUND A TOOTH MODEL, AND A VISUAL INSPECTION FOR ABNORMALITIES. THE RETURNED DEVICE WAS OBSERVED TO HAVE THE SET SCREW WHICH CONTROLS THE TORQUE ON THE HANDLE TO HAVE BEEN TAMPERED/TIGHTENED CAUSING THE HANDLE TO EXCEED THE 8 ¿ 9 OZF-IN REQUIREMENT (AS FOUND 18 OZF-IN) RESULTING IN FLEXSHAFTS USED FOR TESTING TO BREAK/FAIL. BY TIGHTENING THE SET-SCREW AFTER PRESET DURING MANUFACTURING, THE TORQUE SETTING WILL EXCEED THE FLEXSHAFT ASSEMBLY CAPABILITIES WHICH WILL RESULT IN THE FLEXSHAFTS BREAKING. THE RETURNED PRODUCT SET SCREWS WERE RELIEVED TO RETURN TO 9 OZF-IN USING A CALIBRATED TORQUE WATCH AND THEN THE FUNCTIONAL TEST WAS CONDUCTED AND MET SPECIFICATIONS AND ALL FORM/FIT/FUNCTION AS PER 0290-WI-7.5-42-05 SECTION 5.4 AND 0290-IP-7.5-42-05 INSPECTION POINT #3 . THE COMPLAINT IS NOT SUBSTANTIATED AS THE CUSTOMER HAS TAMPERED WITH THE PRODUCT RESULTING IN THE PRODUCT NON-CONFORMANCE. THIS TAMPERING WITH THE AUTOMATE III TIGHTENING DEVICE IS THE DIRECT ROOT CAUSE FOR THE CUSTOMERS REPEAT ISSUES WITH FLEXSHAFT ASSEMBLIES. (NWV). RETAIN 5-5-2025: RETAINS FOR ITEM# 20780 BATCH# 08811097 ARE NOT AVAILABLE FOR REVIEW AS THE PRODUCT IS EXPENSIVE TO MANUFACTURE AND IS NOT COST EFFICIENT TO HOLD A RETAIN FOR EACH BATCH PRODUCED. (NWV) DHR 5-5-2025: DHR FOR ITEM# 663100 LOT# 08968397 HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY ISSUES DURING THE AUTOMATE TOOL REFILL PACKAGING WORK ORDER WITH ALL INSPECTIONS COMPLETED AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY PER 0290-WI-7.5-22-02. ITEM# 20780 BATCH# 08811094 IS THE ATUOMATE III ASSY PRODUCTION WORK ORDER WHICH WAS UTILIZED TO PACKAGE ITEM# 62422602 LOT# 08811097. DHR FOR ITEM# 20780 BATCH# 08811097 HAS ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY ISSUES DURING ASSEMBLY OF THE AUTOMATE III TIGHTENING DEVICE, WITH ALL INSPECTIONS PERFORMED BY AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY AS PER 0290-WI-7.5-42-05 & 0290-IP-7.5-42-05. (NWV).

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, 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 AUTOMATE TOOL REFILL BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032043 AUTOMATE TOOL REFILL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC NOT AVAILABLE D0026631001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown