BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER, DRIVE SHAFT

    MDR report key: 19536217 · Received June 14, 2024

    Report

    Report Number
    1220246-2024-05771
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    January 25, 2021
    Report Date
    June 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867324954
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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, THE SLEEVE WAS RETURNED WITH A REAMER STUCK. THE DEVICE COULD NOT BE MEASURED. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED AS THE SURGEON WAS REAMING THE GLENOID, THE AR-9597-20 DRIVE SHAFT SEEMS TO HAVE COLD WELDED TO THE AR-9597-20 20 ANGLED REAMER SHAFT. THE REP TRIED TO REMOVE IT AFTER THE CASE BUT COULD NOT DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168760 ANGLED REAMER, DRIVE SHAFT MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT UNK 00888867324954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown