BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED REAMER SLEEVE, 10°

    MDR report key: 19483649 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05184
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 12, 2023
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867343436
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-9597-10 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH THE RETURNED MATTING PART AR-9676, BATCH 022239, FOUND RESISTANCE AND FRICTION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES IN THE SLEEVE COLLAR. MULTIPLE DENTS WERE OBSERVED ALONG THE SHAFT CLOSE TO THE LASER ETCHING. BOTH DEVICES ARRIVE SEPARATELY FOR INVESTIGATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON 04/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9676 DRIVE SHAFT GOT STUCK IN AN AR-9597-10 DRILL SLEEVE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. PER FACILITY: "THE AUGMENTED UNIVERS VAULTLOCK GLENOID ANGLED REAMER SLEEVE, 15° DEFECT (AR-9579-10 #(10)37222223 HAS BEEN COMPROMISED. THE ANGLED REAMER INNER DRIVE SHAFT AR-9676 LOT#(10)022239 (WHICH IS NOW ALSO COMPROMISED) REQUIRED FORCE TO BE EXTRACTED FROM AR-9579-10. THERE WAS NOT A DELAY DURING THE PROCEDURE AND THE PATIENT WILL NOT REQUIRE ANOTHER PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099594 ANGLED REAMER SLEEVE, 10° MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. ANGLED REAMER SLEEVE, 10° 37222223 00888867343436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown