BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM SMALL EXTERNAL FIX COMBO CLAMP

    MDR report key: 23510737 · Received November 10, 2025

    Report

    Report Number
    1220246-2025-05037
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    September 12, 2025
    Report Date
    March 9, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDW
    UDI-DI
    00888867520967
    PMA / PMN Number
    K232897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1400-000 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. VISUAL INSPECTION REVEALED THAT THE DEVICE HAD BEEN USED AND WAS RETURNED IN PIECES. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO AN IMPROPER SURGICAL TECHNIQUE. PER THE DIRECTIONS FOR USE (DFU) DFU-0405-EO REVISION 2, ARTHREX SMALL EXTERNAL FIXATION SYSTEM, E. WARNINGS CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. THE ARTHREX SMALL EXTERNAL FIXATION SYSTEM IS INTENDED FOR USE BY INDIVIDUALS WITH ADEQUATE TRAINING AND FAMILIARITY WITH TECHNIQUES ASSOCIATED WITH THE ORTHOPEDIC SURGICAL PROCEDURE EMPLOYED. FOR FURTHER INFORMATION ABOUT TECHNIQUES, COMPLICATIONS AND HAZARDS, CONSULT THE MEDICAL LITERATURE. THE USE OF THESE DEVICES REQUIRES A THOROUGH UNDERSTANDING OF THE TECHNIQUES AND PRINCIPLES OF ORTHOPEDIC SURGERY PROCEDURES. PREOPERATIVE FRAME ASSEMBLY AND AN ADEQUATE SUPPLY OF COMPONENTS ARE RECOMMENDED. INTRAOPERATIVE FRACTURE OR BREAKAGE OF COMPONENTS CAN OCCUR (E.G., DUE TO EXCESSIVE FORCE, EXTENSIVE USE). INSPECT ALL EXTERNAL FIXATION DEVICES AND COMPONENTS PRIOR TO SURGERY. REPLACE WHEN NECESSARY. AVOID DAMAGE TO NERVES, MUSCLES, TENDONS, AND VESSELS BY CAREFUL PLACEMENT OF PINS. AVOID HEAT NECROSIS OF THE SURROUNDING TISSUE AND BONE BY DRILLING PINS SLOWLY THROUGH THE BONE. MAINTAIN METICULOUS DAILY PIN SITE CARE MANAGEMENT TO PREVENT INFECTION.

    Description of Event or Problem · 0

    ON 10/21/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO 1400-000 5.0MM SMALL EXTERNAL FIX COMBO CLAMPS SPONTANEOUSLY FELL APART AFTER BEING AFFIXED TO A PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 10/22/2025: LESS THAN 24 HOURS AFTER THE INITIAL APPLICATION OF THE 1400-000 5.0MM SMALL EXTERNAL FIX COMBO CLAMP DURING A DISTAL RADIUS FRACTURE PROCEDURE, THE CLAMP WAS REPORTED TO HAVE FAILED DUE TO THE INNER COMPONENT SEPARATING AND FALLING APART. THE SURGEON REPLACED THE FAILED CLAMP WITH ANOTHER UNIT OF THE SAME PRODUCT AND LOT NUMBER. HOWEVER, THE FOLLOWING DAY, THE SAME ISSUE OCCURRED WITH THE REPLACEMENT CLAMP. SUBSEQUENTLY, THE SURGEON OPTED TO USE A NON-ARTHREX EXTERNAL FIXATION DEVICE ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 10/28/2025: FOLLOWING THE INITIAL SURGERY THAT OCCURRED ON (B)(6) 2025, THE PATIENT REQUIRED TWO ADDITIONAL HOSPITAL VISITS DUE TO THE FAILURE OF TWO 1400-000 5.0MM SMALL EXTERNAL FIX COMBO CLAMPS. EACH FAILURE OCCURRED APPROXIMATELY 24 HOURS AFTER DISCHARGE AND NECESSITATED THE REPLACEMENT OF THE CLAMP. ALL COMPONENTS OF THE FAILED CLAMPS WERE SUCCESSFULLY RETRIEVED. AFTER THE SECOND REPLACEMENT, THE SURGEON ELECTED TO REMOVE THE EXTERNAL FIXATOR AND PROCEED USING A NON-ARTHREX PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 11/03/2025: THE BOLT AND SCREW BROKE FROM THE INITIAL APPLICATION OF THE 1400-000 5.0MM SMALL EXTERNAL FIX COMBO CLAMP. A PHOTO WAS PROVIDED OF THE ALLEGATION (SEE PHOTO ATTACHMENT). ADDITIONAL INFORMATION WAS RECEIVED ON 11/05/2025: ON (B)(6) 2025, THE ENTIRE 1400-000 5.0MM SMALL EXTERNAL FIX COMBO CLAMP DEVICE WAS REMOVED AND REPLACED WITH A NON-ARTHREX EXTERNAL FIXATOR AS PART OF A REMOVAL AND REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928200 5.0MM SMALL EXTERNAL FIX COMBO CLAMP FIXATN NAIL/BLADE/PLATE COMBO JDW ARTHREX, INC. 5.0MM SMALL EXTERNAL FIX COMBO CLAMP 220175 00888867520967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other