BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP IMPACTOR - M8X1 INTERFACE

    MDR report key: 22307005 · Received June 23, 2025

    Report

    Report Number
    3013223655-2025-00001
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 11, 2025
    Report Date
    June 23, 2025
    Manufacturer
    INCIPIO DEVICES SA
    Product Code
    HWA
    UDI-DI
    07630055302458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOGRAPHS PROVIDED WITH THE EVENT REPORT CONFIRM THE PRODUCT FAILURE. THE STRIKE PLATE HAS FRACTURED AT THE ALIGNMENT GUIDE GROOVE. THE REPORTED ISSUE HAS BEEN IDENTIFIED AS AN ANTICIPATED END OF LIFE FAILURE IN THE PRODUCT RISK MANAGEMENT FILE. THE RISKS ASSOCIATED WITH THE STRIKE PLATE FRACTURE HAVE BEEN REDUCED AS A FAR AS POSSIBLE AND RESIDUAL RISK IS LOW AND ACCEPTABLE. OCCURRENCE LEVELS REMAIN ACCEPTABLE. THE FAILURE WILL CONTINUE TO BE TRACKED AS PART OF ROUTINE TREND MONITORING ACTIVITIES. THE CAUSE OF THE ISSUE IS FATIGUE FOLLOWING MANY YEARS OF USE AND REUSE. NO CORRECTIVE ACTION IS CONSIDERED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    THE BACK PART OF THE IMPACTOR BROKE WHILE THE CUP WAS BEING IMPACTED. SINCE THE IMPACTION WAS ALMOST COMPLETE, NO BACKUP INSTRUMENTS WERE USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. EVENT OCCURED IN JAPAN. PRODUCT IS ALSO MARKETED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927581 OFFSET CUP IMPACTOR - M8X1 INTERFACE OFFSET CUP IMPACTOR HWA INCIPIO DEVICES SA 01.15.10.0556 20J10444 07630055302458

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown