BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 FORCEPS

    MDR report key: 16794331 · Received April 24, 2023

    Report

    Report Number
    2515379-2023-00071
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Report Date
    May 10, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(6) 2023: RETURNED PRODUCT 1 PAIR FORCEPS (GEN 1) BATCH A050820 BROKEN AT THE ¿PIN¿ LOCATION THUS SUBSTANTIATING THE CUSTOMERS COMPLAINT. RECEIVING INSPECTION DHR TO BE EVALUATED. (NWV) (B)(6) 2023: INCOMING RETAINS ARE KEPT FROM THE INITIAL BATCH OF 68 SAMPLES TESTED BACK IN (B)(6) 2020 AND ARE NO LONGER AVAILABLE FOR REVIEW (DISCARDED AFTER 6 MONTHS PER NORMAL PROCEDURE). DHR (B)(6) 2023: INCOMING/RECEIVING DOCUMENTS FOR LOT# A050820 FORCEPS HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. ALL INCOMING SUPPLIER DOCUMENTATION/CERTIFICATIONS MEET SPECIFICATIONS AS WELL AS ALL VISUAL, DIMENSIONAL, AND FUNCTIONAL TESTS AS PER 0290-IP-RI-INSTRUMENTS. A TOTAL OF 3,500 FORCEPS WAS RECEIVED ON (B)(6) 2020 AND AQL SAMPLING SIZE FOR VISUAL INSPECTION WAS N=29, AND FUNCTIONAL/DIMENSIONAL N=68PCS AND N=5 HARDNESS TESTING, WITH ALL INSPECTED FORCEPS MEETING ALL SPECIFICATIONS PER PROCEDURE. (NWV). ROOT CAUSE: NOT DETERMINED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PALODENT V3 FORCEPS BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566450 PALODENT V3 FORCEPS INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown