BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V3 RING UNIVERSAL (GREEN) 2 PACK

    MDR report key: 17737869 · Received September 13, 2023

    Report

    Report Number
    2515379-2023-00100
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Report Date
    October 2, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659900V1
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: RETURN 9-29-2023: RETURNED PRODUCT 1 V3 RING UNIVERSAL (GREEN, NEW AND IMPROVED DESIGN V5) WITH ONE OF THE TYNES BROKEN OFF/MISSING. OVERMOLDING DATE CODES ¿B¿ FOR FEBRUARY AND ¿N¿ FOR 2022. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV) RETAIN 9-29-2023: FINAL PACKAGING PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RING OVER-MOLDING RETAIN FROM ITEM# (B)(4) BATCH# 05104833 WAS PULLED, REVIEWED, AND DEEMED ACCEPTABLE AS PER 0290-IP-7.5-60-58 AND MEET ALL FORM/FIT/FUNCTION. (NWV) DHR 9-29-2023: DHR FOR ITEM# (B)(4) LOT# 05122264 HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY PRODUCTION ISSUES WHILE PACKAGING/LABELING THE V3 RING UNIVERSAL (GREEN) 2 PACK. WORK ORDER (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDER/RUN ITEM# (B)(4) BATCH# 05104833. THE OVER-MOLDING WORK ORDER IS ONLY TO MOLD THE TYNES TO THE SPRING. DHR REVIEW FOR MOLDING ITEM# (B)(4) BATCH# 05104833 DID NOT INDICATE ANY PRODUCTION ISSUES, NOR ANY COMMENTS NOTED, HOWEVER THERE IS A NON-CONFORMANCE WITH THE DOCUMENTATION AS THE QC FINAL INSPECTION WAS NOT DOCUMENTED AS PER 0290-IP-7.5-60-58 AND LEFT BLANK. NC-2023-3023 HAS BEEN INITIATED FOR THE DHR DOCUMENTATION NON-CONFORMANCE AND THE QUALITY DEPARTMENT HAS BEEN NOTIFIED. (NWV)

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT V3 RING UNIVERSAL (GREEN) 2 PACK BROKE DURING USE. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77673 V3 RING UNIVERSAL (GREEN) 2 PACK INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05122264 D002659900V1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown