BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVL ANGLED REAMER SLEEVE ASSEMBLY, 15

    MDR report key: 19429658 · Received May 30, 2024

    Report

    Report Number
    1220246-2024-04447
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    October 13, 2022
    Report Date
    May 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    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 IS CONFIRMED. ONE UNPACKAGED AR-9597-15, UNIVERS VAULTLOCK® AUGMENTED GLENOID ANGLED REAMER SLEEVE, 15° DEFECT, BATCH NUMBER 050243, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE AR-9676 -ANGLE REAMER DRIVER SHAFT IS STUCK WITHIN THE MATING DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON 10/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9297-15 AUGMENTED GLENOID ANGLED REAMER SLEEVE AND AN AR-9676 REAMER DRIVE SHAFT HEAT WELDED TOGETHER DURING THE REAMING PROCESS. THEY COULD NOT BE ROTATED INDEPENDENTLY AND WERE UNABLE TO SEPARATE. THIS WAS DISCOVERED DURING AN AUGMENT VAULTLOCK PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580802 AVL ANGLED REAMER SLEEVE ASSEMBLY, 15 ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 15 052043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown