BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 FORCEPS

    MDR report key: 15880669 · Received November 29, 2022

    Report

    Report Number
    2515379-2022-00058
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Report Date
    January 9, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    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

    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.

    Additional Manufacturer Narrative · 0

    1-5-2023: RETURNED PRODUCT 1 PAIR OF FORCEPS WITH LOT A070121 ETCHED ON THE HANDLE. THE RETURNED FORCEPS BROKE IN HALF AT THE ¿PIN¿ COMPONENT OF THE FORCEPS AS THE CUSTOMER DESCRIBES. THE COMPLAINT IS CONSIDERED SUBSTANTIATED. (NWV). DHR: 1-5-2023: INCOMING/RECEIVING DOCUMENTS FOR LOT# A070121 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 (B)(4) FORCEPS WAS RECEIVED ON 7-21-2021 AND AQL SAMPLING SIZE FOR VISUAL INSPECTION WAS N=68, AND FUNCTIONAL/DIMENSIONAL N=68PCS AND N=5 HARDNESS TESTING, WITH ALL INSPECTED FORCEPS MEETING ALL SPECIFICATIONS PER PROCEDURE. (NWV). RETAINED: 1-5-2023: INCOMING RETAINS ARE KEPT FROM THE INITIAL BATCH OF 68 SAMPLES TESTED AND THEREFORE MEET SPECIFICATIONS AS PER 0290-IP-RI-INSTRUMENTS. (NWV). ROOT CAUSE: NOT DETERMINED. CONCLUSION: INDETERMINABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677720 PALODENT V3 FORCEPS INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC A070121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown