BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 24691899 · Received March 25, 2026

    Report

    Report Number
    8030965-2026-02821
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 9, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    10886982297396
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION OF " 03.043.029, AIM-ARM RADIOLUC" REVEALED THAT THE LATCH WAS BROKEN. THESE FORCES MAY PREVENT ACCURATE TARGETING THROUGH PROXIMAL LOCKING HOLES AND DAMAGE THE DRILL BITS. NOTE: THE PROXIMAL AP SCREW IS INSERTED THROUGH THE GUIDING HOLE IN THE INSERTION HANDLE AND DOES NOT REQUIRE AIMING ARM TO BE ATTACHED. ASSEMBLE THE THREE-PART TROCAR ASSEMBLY (PROTECTION SLEEVE, DRILL SLEEVE, AND TROCAR). ALIGN THE TRIANGULAR MARKING AT THE TIP OF THE PROTECTION SLEEVE WITH THE MARKING BESIDE THE DESIRED HOLE ON THE AIMING ARM, AND INSERT THE THREE-PART TROCAR ASSEMBLY THROUGH THE AIMING ARM. MAKE A STAB INCISION AND INSERT THE TROCAR TO THE BONE. TWIST THE PROTECTION SLEEVE BY A QUARTER TURN TO LOCK IT INTO PLACE. REMOVE THE TROCAR. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE AIM-ARM RADIOLUC WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO CAUSE NOT ESTABLISHED, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: PART # 03.043.029. LOT # 2024221. RELEASE TO WAREHOUSE DATE: 09. APR. 2021. MANUFACTURING SITE: SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2026 THE SURGEON WAS INSERTING A TIBIA NAIL. THE NAIL WAS INSERTED AND THE JIG WAS THEN HOOKED ONTO THE NAIL INSERTOR. WHEN THE AIMING ARM WAS CLICKED ONTO THE JIG THE LATCH BROKE. NO PATIENT HARM WAS CREATED AND WE OPENED ANOTHER SET TO COMPLETE THE PROCEDURE. NO PATIENT HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755207 AIMING ARM/ RADIOLUCENT NAIL, FIXATION, BONE JDS SYNTHES GMBH 2024221 10886982297396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown