BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER GENERAL HUMERAL REAMING GUIDE

    MDR report key: 11169658 · Received January 14, 2021

    Report

    Report Number
    3005180920-2021-00040
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971234031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12-JAN-2020: LOT 1850239: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. MEDACTA R&D EVALUATION OF THIS EVENT: THE INSTRUMENT USED DURING THE SURGERY AS A SUBSTITUTE OF THE MISSING INSTRUMENT WAS NOT APPROPRIATE DUE TO IT HAS DIFFERENT DIMENSIONS.

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS DISCOVERED THAT THE HUMERAL REAMING GUIDE WAS MISSING IN THE SET. THE SURGEON USED THE GLENOSPHERE GUIDE INSTEAD AND THE PATIENT'S HUMERUS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65456 SHOULDER GENERAL HUMERAL REAMING GUIDE SHOULDER HUMERAL REAMING GUIDE LXH MEDACTA INTERNATIONAL SA 04.01.10.0073 1850239 07630971234031

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other