BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM, DRL BIT, CANNULATED, REUSABLE

    MDR report key: 21618967 · Received March 17, 2025

    Report

    Report Number
    1220246-2025-00968
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 27, 2025
    Report Date
    August 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867319592
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-8770-02-RU, 5.0 MM DRILL BIT, BATCH 032242, WAS RECEIVED FOR INVESTIGATION. UPON EVALUATION, THE DEVICE'S TIP AND PROXIMAL END WERE DAMAGED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SUCH AS MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE. REFER TO INVESTIGATION PHOTOS. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE DEVICE BROKE. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566538 5.0MM, DRL BIT, CANNULATED, REUSABLE DRILL BIT HTW ARTHREX, INC. 5.0MM, DRL BIT, CANNULATED, REUSABLE 032242 00888867319592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown