BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5

    MDR report key: 11916524 · Received June 1, 2021

    Report

    Report Number
    3000931034-2021-00260
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 3, 2021
    Report Date
    October 29, 2021
    Product Code
    KWS
    UDI-DI
    03700386941054
    PMA / PMN Number
    K122698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED BASED ON A VISUAL INSPECTION DONE ON A PART OF THE SAME LOT CODE. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. A CAPA WAS OPENED AND THE AFFECTED PARTS WERE RECALLED.

    Description of Event or Problem · 0

    ABSENCE OF A DIAL TO REPRODUCE THE TEST IN ITS FINAL VERSION: IMPOSSIBLE TO IDENTIFY THE POSITIONING OF THE PLATFORM ON THE ROD, AND THE POSITIONING OF THE INSERT ON THE PLATFORM IMPLANT NOT CONFORM WITH THE NEEDED ONE. APPARENTLY THE PROBLEM HAS ALREADY BEEN REPORTED BECAUSE THE PLATFORM WOULD IN FACT BE A CENTERED 0 OF REF DWF 500 IN THE PACKAGING OF A DWF 510. NO SUBSTITUTE DEVICE SINCE ONLY ONE UNIT IN THE DEPOSIT ; APPROXIMATE AND RANDOM POSITIONING AT THE END. PROLONGATION OF FIFTEEN MINUTES OF THE SURGERY AND MANY HESITATIONS DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ABSENCE OF A DIAL TO REPRODUCE THE TEST IN ITS FINAL VERSION: IMPOSSIBLE TO IDENTIFY THE POSITIONING OF THE PLATFORM ON THE ROD, AND THE POSITIONING OF THE INSERT ON THE PLATFORM IMPLANT NOT CONFORM WITH THE NEEDED ONE. APPARENTLY THE PROBLEM HAS ALREADY BEEN REPORTED BECAUSE THE PLATFORM WOULD IN FACT BE A CENTERED 0 OF REF DWF 500 IN THE PACKAGING OF A DWF 510. NO SUBSTITUTE DEVICE SINCE ONLY ONE UNIT IN THE DEPOSIT ; APPROXIMATE AND RANDOM POSITIONING AT THE END. PROLONGATION OF FIFTEEN MINUTES OF THE SURGERY AND MANY HESITATIONS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813772 FLEX SHOULDER SYSTEM REVERSED TRAY DIA. 40 TH 0 ECC 1.5 PROSTHESIS SHOULDER JOINT METAL KWS DIA. 40 TH 0 ECC 1.5 1197AW 03700386941054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other