BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL NON-CANNULATED, 4MM

    MDR report key: 22118645 · Received May 30, 2025

    Report

    Report Number
    1220246-2025-02317
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867004450
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE FLUTE'S TIP WAS WORN OUT AND HAD SCRATCHES ON THE FLUTE'S SURFACE OF THE COUNTERSINK FOR 6.5 MM HCS -FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT SPECIFIED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, WHICH CAN BE ATTRIBUTED TO MISALIGNED INSERTION AND/OR APPLICATION OF EXCESSIVE MECHANICAL FORCE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE, KHE, 30-MAY2025 THE DEVICE WAS PART OF THE LOAN SET DLS-GBL-IN-10145474.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736921 DRILL NON-CANNULATED, 4MM DRILL BIT HWE ARTHREX, INC. DRILL NON-CANNULATED, 4MM 022431 00888867004450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown