BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE COMBINATION CLAMP

    MDR report key: 24944541 · Received April 21, 2026

    Report

    Report Number
    1220246-2026-02323
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867241251
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 0

    ON 01-APR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT SEVEN AR-8964-07 LARGE COMBINATION CLAMPS, FOUR AR-8964-27 STRAIGHT ATTACHMENT ARMS, TWO AR-8964-08 MULTI-PIN CLAMPS (LARGE), AND THREE AR-8964R-450 CARBON RODS (450 MM) WERE USED IN A KNEE-SPANNING EXTERNAL FIXATION CONSTRUCT WITH THE ARTHROFX EXTERNAL FIXATION SYSTEM DURING A SURGICAL PROCEDURE PERFORMED ON (B)(6) 2026. THE CONSTRUCT INCLUDED TWO 5 MM ARTHROFX SCHANZ PINS PLACED IN THE FEMUR AND TWO 5 MM ARTHROFX SCHANZ PINS PLACED IN THE TIBIA TO ADDRESS A PROXIMAL TIBIAL FRACTURE. INTRAOPERATIVELY, THE SURGEON APPLIED DISTRACTION, BROUGHT THE FRACTURE TO LENGTH, TIGHTENED ALL COMBINATION CLAMPS, AND COMPLETED THE PROCEDURE WITHOUT ISSUE. WITHIN APPROXIMATELY 36¿48 HOURS POSTOPERATIVELY, FOLLOW-UP X-RAY IMAGING DEMONSTRATED LOSS OF FRACTURE REDUCTION, AND THE EXTERNAL FIXATOR WAS NOTED TO HAVE SLIPPED. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2026. DURING THE REVISION, THE SURGEON INITIALLY ATTEMPTED TO REUSE THE EXISTING ARTHROFX 5 MM SCHANZ PINS; HOWEVER, WHEN DISTRACTION WAS APPLIED USING AN ALTERNATE MANUFACTURER¿S COMBINATION CLAMPS, INTRAOPERATIVE X-RAY IMAGING DEMONSTRATED BENDING OF THE ARTHROFX PINS. THE PINS WERE REMOVED, AND THE EXTERNAL FIXATOR WAS COMPLETED USING AN ALTERNATE MANUFACTURER¿S SYSTEM. NO PHYSICAL HARM TO THE PATIENT WAS REPORTED AS A RESULT OF THE INSTRUMENTATION; HOWEVER, THE EXTERNAL FIXATOR FAILED TO MAINTAIN ITS INTENDED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005558 LARGE COMBINATION CLAMP MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. LARGE COMBINATION CLAMP 2492401 00888867241251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other