BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE

    MDR report key: 23956948 · Received January 5, 2026

    Report

    Report Number
    1220246-2026-00035
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 15, 2025
    Report Date
    February 13, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867354258
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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-3610CT STRAIGHT SPEAR CT FIBERTAK, BATCH 0072437, WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED A BROKEN DRILL INSIDE THE DEVICE, WITH THE DRILL TIP BENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE EXTENT OF THE DEVICE'S DAMAGE. THE OBSERVED DAMAGE IS MOST CONSISTENT WITH USE-RELATED FACTORS, SUCH AS MISALIGNED INSERTION AND/OR PRYING OR LEVERAGING OF THE DRILL DURING USE, RESULTING IN BENDING AND FRACTURE. BASED ON THE PHYSICAL EVIDENCE OBSERVED, THE COMPLAINT ALLEGATION IS CONFIRMED. REFER TO THE ATTACHED INVESTIGATION PHOTOGRAPHS.

    Description of Event or Problem · 0

    ON 15-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3610CT STRAIGHT SPEAR FIBERTAK DRILL BIT WAS BOUND UP, STUCK AND WOULD NOT COME OUT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282070 STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. STRAIGHT SPEAR, CT, FIBERTAK, REUSABLE 0072437 00888867354258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown