BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVL 6MM SUPERIOR DRILL, MODULAR

    MDR report key: 19382617 · Received May 23, 2024

    Report

    Report Number
    1220246-2024-03741
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    March 3, 2023
    Report Date
    May 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867350472
    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 IS CONFIRMED. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE FLUTES HAVE NICKS AND ABRASION MARKS, AND THE DRILL IS BENT. ALSO, THE SPRING IS MISSING. 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 (B)(6) 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
    1617525 AVL 6MM SUPERIOR DRILL, MODULAR POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. AVL 6MM SUPERIOR DRILL, MODULAR 022110 00888867350472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown