BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFORM CAPSULAR TENSION RING

    MDR report key: 20638463 · Received November 8, 2024

    Report

    Report Number
    1000447964-2024-00007
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Report Date
    November 8, 2024
    Manufacturer
    MORCHER GMBH
    Product Code
    MRJ
    PMA / PMN Number
    P010059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF PRODUCTION RECORDS SUCH AS THE DEVICE HISTORY RECORD OF LOT CEEBHO SHOWED NO IRREGULARITIES OR DEVIATIONS IN RELATION TO THE PRODUCT PROBLEM DESCRIPTION. THE REVIEW CONFIRMS THAT THE PRODUCTION OF THE AFFECTED PRODUCT WAS IN ACCORDANCE WITH THE QUALITY MANAGEMENT SYSTEM AND APPLICABLE PROCEDURES. THE RECORDS CONFIRM COMPLIANCE WITH THE PRODUCT SPECIFICATION AND PRODUCT CONFORMITY. ALTHOUGH REQUESTED MULTIPLE TIMES, THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. A PRODUCT INVESTIGATION COULD NOT BE CONDUCTED. ALTHOUGH REQUESTED MULTIPLE TIMES, NO INFORMATION REGARDING THE USER EXPERIENCE AND USED INSTRUMENTS SUCH AS THE INJECTOR/LOADER WAS PROVIDED. A REVIEW OF THE COMPLAINT RECORDS SHOWED THAT THE USER FACILITY (RIVER DRIVE SURGERY CENTER, 619 RIVER DRIVE CENTER 1, NJ) WAS ALREADY MARKED IN 2023 BY AN INCREASED NUMBER OF PRODUCT PROBLEM NOTIFICATIONS. ADDITIONALLY, IN 2024, THREE FURTHER PRODUCT PROBLEMS WERE REGISTERED FROM THE SAME USER FACILITY, ALL ORIGINATING FROM THE SAME USER (B)(6). THE OCCURRENCE OF COMPLAINTS DUE TO A DEFECTIVE (BROKEN) RING IS RETROSPECTIVELY PROVEN TO BE "RARELY" SINCE THE YEAR 2013. THE TREND ANALYSIS OF THE COMPLAINT RATES IN THE LAST 11 YEARS SHOWS AN INDICATION FOR A DECREASING TREND. THE OVERALL COMPLAINT RATE IS VERY LOW (B)(4). THE RISK ANALYSIS AND THE REVIEW OF THE IFU WERE CONSIDERED AS ACCEPTABLE. BASED ON THE PROVIDED INFORMATION, THE ROOT CAUSE OF THE PRODUCT PROBLEM COULD NOT BE DETERMINED. IT IS SUSPECTED THAT USER-RELATED FACTORS SUCH AS HANDLING OR LOADING TECHNIQUES MIGHT HAVE CONTRIBUTED TO THE PRODUCT PROBLEM AS THE RING BROKE DURING MANIPULATION AND THREE FURTHER PRODUCT PROBLEMS ARE LINKED TO THE SAME USER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 IF ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    "DEFECTIVE WAS ALL THAT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816015 REFORM CAPSULAR TENSION RING CAPSULAR TENSION RING MRJ MORCHER GMBH ACTR11 CEEBHO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown