BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM, DRL BIT, CANNULATED, REUSABLE

    MDR report key: 25283487 · Received May 26, 2026

    Report

    Report Number
    1220246-2026-02993
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867319592
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-8770-02-RU, 5.0MM, DRL BIT, CANNULATED, REUSABLE, BATCH NUMBER 916440, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT AN AR-8737-56 GUIDE WIRE PLUNGER IS STUCK INSIDE THE CANNULA (SEE EVALUATION PICTURES 3 + 5). FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOOT SURGERY THE DRILL BIT BROKE OFF. 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. UPDATE 12-MAY-2026: DURING INCOMING INSPECTION OF THE RETURNED DEVICES, IT WAS FOUND THAT THE INITIALLY PROVIDED COMPLAINT INFORMATION WAS INCORRECT. DURING THE VISUAL EVALUATION IT WAS FOUND THAT THE DRILL BIT BECAME STUCK INSIDE THE GUIDE AND NO PART OF THE DEVICE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185334 5.0MM, DRL BIT, CANNULATED, REUSABLE DRILL BIT HTW ARTHREX, INC. 5.0MM, DRL BIT, CANNULATED, REUSABLE 916440 00888867319592

    Patients

    Seq Age Sex Outcome Treatment
    1