BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM

    MDR report key: 24308866 · Received February 10, 2026

    Report

    Report Number
    1220246-2026-00512
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665000986
    PMA / PMN Number
    K191598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE COMPLAINT ALLEGATION IS CONFIRMED. - ONE UNPACKAGED 0234-155 SERIAL/BATCH NUMBER 211146 WAS RECEIVED FOR INVESTIGATION. - FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. - VISUAL INSPECTION NOTED THAT THE DEVICE IS SIGNIFICANTLY DAMAGED WHERE THE FEMORAL SHAFT ATTACHES. - THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE/USE ERROR DUE TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 17-JAN-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A 0234-155 15.5 MM MODULAR FLEXIBLE REAMER HEAD BROKE DURING THE INTRAMEDULLARY REAMING OF A FEMORAL SHAFT. THE HIP NAIL PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO OTHER PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 04-FEB-2026. THE REP ADVISED THAT THERE WERE TWO SMALL FRAGMENTS CREATED IN ADDITION TO THE LARGER REMAINING PORTION OF THE REAMER THAT WAS RETRIEVED, AND THOSE TWO FRAGMENTS REMAINED IN THE PATIENT. THE REP STATED THAT NO ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENTS, AS THEY WERE MIDSHAFT AND DEEMED IMPOSSIBLE TO RETRIEVE. THERE WAS NO DELAY ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42483 MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM REAMER HSB ARTHREX, INC. MODULAR FLEXIBLE REAMER HEAD, Ø15.5MM 211146 00848665000986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown