BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID REAMER X-LARGE

    MDR report key: 19212015 · Received April 30, 2024

    Report

    Report Number
    1220246-2024-02595
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    October 20, 2021
    Report Date
    April 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867239104
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED. ONE UNPACKAGED AR-9231GRPP, BATCH 021631 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THE PRESENCE OF CHIPPING/GENERAL WEAR ACROSS THE CUTTING EDGES AT THE DISTAL END OF THE REAMER. A PROBABLE CAUSE CAN BE ATTRIBUTED TO WEAR AND TEAR DAMAGE ACCUMULATED THROUGH REPEATED USAGE.

    Description of Event or Problem · 0

    ON 10/20/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE FOLLOWING REAMERS WERE FOUND TO BE DULL: AR-9288GRPP, AR-9229GRPP, AR-9230GRPP AND AR-9231GRPP. THE SURGEON USED ALL REAMERS, FROM SMALLEST (AR-9288GRPP) TO LARGEST (AR-9231GRPP) UNTIL THE DEPTH DESIRED FOR EACH WAS REACHED. AFTER COMPLETION WITH THE EXTRA-LARGE REAMER, THE SURGEON WENT BACK TO THE SMALL REAMER AND BEGAN TO REAM THE INSERTION SITE. DURING REAMING THE SURGEON USED FORCE ON THE SMALL REAMER CAUSING THE DEVICE TO REAM MORE THAN THE DESIRED DEPTH ON THE GLENOID. THIS PORTION OF THE PROCEDURE WAS COMPLETED USING EXTRA CEMENT TO ACHIEVE GOOD FIXATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176076 UNIVERS VAULTLOCK GLENOID REAMER X-LARGE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. UNIVERS VAULTLOCK GLENOID REAMER X-LARGE 021631 00888867239104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown