BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRL BIT, 5.0MM, CANN.

    MDR report key: 19472059 · Received June 5, 2024

    Report

    Report Number
    1220246-2024-04987
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    December 16, 2022
    Report Date
    June 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867266032
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION. HOWEVER, DUE TO THE DEVICE BEING RETURNED UNPACKAGED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED. THIS COMPLAINT WILL BE INCLUDED IN TRENDING PER (B)(4).

    Description of Event or Problem · 0

    ON 12/16/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT THE AR-8750-09, AR-8770-02, AR-8750K, AND AR-8770K K-WIRES OF THE 5.0/7.0 KEEP GETTING STUCK IN THE DRILL BITS AND PULLING OUT OF THE PATIENT, THEREFORE LOSING THE SURGEONS K-WIRE POSITIONING. NO PATIENT AFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806607 DRL BIT, 5.0MM, CANN. DRILL BIT HTW ARTHREX, INC. DRL BIT, 5.0MM, CANN. 1392237 00888867266032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown