BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE RESECT PROTECTOR,SZ M/46.0MM

    MDR report key: 19415299 · Received May 29, 2024

    Report

    Report Number
    1220246-2024-04199
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    March 3, 2023
    Report Date
    May 29, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 CONFIRMED. UPON VISUAL EVALUATION, OXIDATION/DISCOLORATION WAS OBSERVED ON BOTH SIDES OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 03/03/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9221AG DRILL IS BENT, AR-9628 TIP IS BROKEN, AND AR-9401-40, AR-9401-46, AR-9401-50 RESECT PROTECTOR ARE RUSTY. CASE INVOLVEMENT, NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630157 ECLIPSE RESECT PROTECTOR,SZ M/46.0MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. ECLIPSE RESECT PROTECTOR,SZ M/46.0MM 052122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown