BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM DRILL BIT

    MDR report key: 19490405 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05221
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    March 3, 2023
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 IS CONFIRMED. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE DISTAL END OF THE DRILL WAS BROKEN OFF. HOWEVER, THE BROKEN PIECE WAS NOT RETURNED FOR INVESTIGATION. ALSO, THE LASER MARKING HAS FADED. 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. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE.

    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
    1311286 3.0MM DRILL BIT ORTHOPEDIC MANUAL SURG INSTR HTW ARTHREX, INC. 3.0MM DRILL BIT 021907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown