BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 FORCEPS

    MDR report key: 18484026 · Received January 10, 2024

    Report

    Report Number
    2515379-2024-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Report Date
    February 5, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659810V1
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: 1-31-2024: PRODUCT RETURNED 1 PAIR GEN 2 FORCEPS BATCH# A100121 BROKEN AT THE HANDLE AT THE CUSTOMER DESCRIBES THUS SUBSTANTIATING THE CUSTOMERS COMPLAINT. NOTE: THIS IS THE FIRST COMPLAINT FOR BROKEN FORCEPS FOR ITEM# (B)(4) BATCH# A100121. (NWV). 1-31-2024: INCOMING RETAINS ARE NO LONGER AVAILABLE FOR REVIEW AS PER 0290-WI-8.2-07 WHICH STATES RETENTION SAMPLES MUST BE MAINTAINED FOR A MINIMUM OF SIX MONTHS (RECEIVED IN 01-2022). (NWV). 1-31-2024: INCOMING/RECEIVING DOCUMENTS FOR ITEM# (B)(4) (GEN 2 FORCEPS) BATCH# A100121 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-7.5-80-12. A TOTAL OF (B)(4) FORCEPS WAS RECEIVED ON 1-20-2022 AND AQL SAMPLING SIZE FOR VISUAL INSPECTION WAS N=29, AND FUNCTIONAL & DIMENSIONAL N=68PCS FOR EACH TEST WITH ALL INSPECTED FORCEPS MEETING ALL SPECIFICATIONS PER PROCEDURE. (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 RESULTS ARE NOT AVAILABLE 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 PALODENT V3 FORCEPS BROKE DURING USE. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989043 PALODENT V3 FORCEPS INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC A100121 D002659810V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown