BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V3 RING UNIVERSAL (GREEN) 2 PACK

    MDR report key: 16815793 · Received April 26, 2023

    Report

    Report Number
    2515379-2023-00072
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Report Date
    June 14, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    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

    INVESTIGATION TYPE RETURN (B)(6) 2023: RETURNED PRODUCT 4 UNIVERSAL RINGS (GREEN ¿ TRIODENT) OF WHICH 3 WERE BROKEN IN HALF AND 1 EXTREMELY WORN OUT/EVIDENCE OF LONG-TERM USAGE AND WAS NOT BROKEN/DAMAGED. DATE CODE FOR THE 1 NON-BROKEN RING ¿C¿ FOR (B)(6) AND ¿I.¿ FOR 2019, I WHICH THIS RING EXCEEDS USEFUL LIFE OF 2 YEARS FROM MANUFACTURING DATE (SEE ATTACHED COMMUNICATION). THE OTHER 3 DATE CODES ARE AS FOLLOWS: 1 WITH ¿K¿ FOR (B)(6) WITH ¿M¿ FOR 2021 AND THE OTHER 2 ARE THE SAME AND ARE ¿I¿ FOR (B)(6) WITH ¿M¿ FOR 2021. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV). INVESTIGATION TYPE RETAIN 6-13-2023: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING LOT OF UNIVERSAL RINGS BATCH 05043110 WAS REVIEWED AND INSPECTED PER 0290-IP-7.5-60-58 AND WERE FOUND ACCEPTABLE. (NWV) DHR 6-13-2023: DHR FOR ITEM# 403342 BATCH# 05243872 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 3 DIFFERENT OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS OF ITEM 220004 (UNIVERSAL/GREEN RING) IN WHICH WERE 05104833 (PRODUCED 02-2022), 05043110 (PRODUCED 11-2021) & 05104834 (PRODUCED 02-2022). DHR FOR ONLY BATCH# 05043110 HAS ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE (ONLY BATCH MANUFACTURED IN NOVEMBER 2021 WITH DATE CODE ¿K¿ AND ¿M¿ FROM VERIFIED RETURNED PRODUCT). DHR REVIEW DID NOT INDICATE ANY ISSUES IN PRODUCTION, WITH ALL INSPECTIONS PERFORMED AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY AS PER 0290-WI-7.5-60-14 & 0290-IP-7.5-60-58. DHR EVALUATION NOT CONDUCTED ON ANY OTHER BATCHES AS NO ADDITIONAL BATCH INFORMATION WAS PROVIDED IN CASE AND AS CONFIRMED BY RETURNED PRODUCT DATE CODES, THE OTHER 3 RETURNED WERE NOT FROM ITEM# 403342 BATCH# 05243872. (NWV).

    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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610193 V3 RING UNIVERSAL (GREEN) 2 PACK INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05243872

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown