BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDLR RVS RMR 46MM CNLTD

    MDR report key: 15409929 · Received September 13, 2022

    Report

    Report Number
    1038671-2022-01096
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    February 17, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JXH
    UDI-DI
    10885862087829
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    (H3) THE BROKEN CANNULATED REAMER REPORTED MAY HAVE BEEN DUE TO INCOMPLETE SEATING OF THE REAMER ON THE TRI-DRIVER PRIOR TO USE, WHICH LED TO FRACTURING OF THE REAMER POST DURING REAMING. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 912, POST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE REAMING THE GLENOID, IT FRACTURED OFF THE SQUARE PIECE THAT ATTACHES TO THE TRI DRIVE. REP BELIEVES THE TECH DID NOT FULLY SEAT THE REAMER ON THE TRI DRIVE AND WHEN HE STARTED REAMING. NOTHING WAS DAMAGED ON THE PATIENTS END. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. IT FRACTURED OUTSIDE THE 81 Y/O MALE PATIENT AND FROM THE TRI DRIVE CONNECTION PIECE MOST DISTAL. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952328 MDLR RVS RMR 46MM CNLTD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT JXH EXACTECH, INC. 321-35-46 133341008 10885862087829

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male