BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT PLUS PIN TWEEZERS

    MDR report key: 19091694 · Received April 11, 2024

    Report

    Report Number
    2515379-2024-00018
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Report Date
    May 10, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D0026598201
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT 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 5-9-2024: RETURNED PRODUCT 1 PAIR OF PALODENT PLUS PIN TWEEZERS ITEM# 759820 BATCH# 100322 WAS INSPECTED AND CONFIRMED TO BE MISSING THE ¿PIN¿ AT THE TIPS OF THE TWEEZERS WHICH AIDS IN HOLDING THE TAB MATRICES IN PLACE WITHIN THE INSTRUMENT. THE RETURNED PRODUCT IS NOT TO SPECIFICATION AND DHR REVIEW WILL BE CONDUCTED. (NWV) RETAIN 5-9-2024: INCOMING RETAIN FOR ITEM# 759820 BATCH# 100322 IS NOT AVAILABLE FOR REVIEW AS PER (B)(4) WHICH STATES RETENTION SAMPLES MUST BE MAINTAINED FOR A MINIMUM OF SIX MONTHS (RECEIVED 10-4-2022). (NWV DHR 5-9-2024: RECEIVING INSPECTION FOR ITEM# 759820 BATCH# 100322 HAS BEEN ATTACHED TO THIS CASE. ALL INCOMING SUPPLIER DOCUMENTATION/CERTIFICATIONS MEET SPECIFICATIONS AS WELL AS ALL VISUAL, DIMENSIONAL, AND FUNCTIONAL TESTS AS PER 0290-IP-7.5-80-15. A TOTAL OF (B)(4) PIN TWEEZERS WAS RECEIVED ON 10-4-2022 AND AQL SAMPLING SIZE FOR VISUAL WAS (B)(4) PCS AND FUNCTIONAL EACH TEST WAS (B)(4) PCS, WITH ALL INDIVIDUAL PIN TWEEZERS MEETING ALL SPECIFICATIONS PER PROCEDURE. REVIEW OF THE INSPECTION RESULTED IN NO ISSUES AND ALL INSPECTIONS WERE PERFORMED ON THE LOT AND DEEMED ACCEPTABLE BY QUALITY. (NWV).

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PALODENT PLUS PIN TWEEZERS - THE PRONG BROKE OFF OF THE NEW PALODENT TWEEZERS. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406321 PALODENT PLUS PIN TWEEZERS INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC ZZ600L (DON'T THINK THIS IS RI D0026598201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown