BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 24726998 · Received March 30, 2026

    Report

    Report Number
    8030965-2026-02926
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 11, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    10886982297396
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: H3, H6: PART: 03.043.029. LOT: 2041039. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 26 MAR 2025. EXPIRATION DATE; NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. PHOTOS WERE PROVIDED FOR REVIEW, HOWEVER THE PHOTOS ONLY SHOW PART AND LOT NUMBER AND NO OTHER OBSERVATION PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE PHOTOGRAPHS PROVIDED CONTAINED INSUFFICIENT EVIDENCE OF THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, 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 COMPLAINT CONDITION. AS PART OF 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSERTION HANDLE/ RADIOLUCENT MEDIUM AND AIM-ARM RADIOLUC WERE INVOLVED IN AN EVENT DURING A PARAPATELLAR TIBIA NAIL INSERTION PROCEDURE. WHILE PLACING PROXIMAL INTERLOCKING SCREWS USING THE AIMING ARM, THE DRILL BIT STRUCK THE NAIL, RESULTING IN A SLIGHT PROCEDURAL DELAY OF 3-5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO REPORTED PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790292 AIMING ARM/ RADIOLUCENT NAIL, FIXATION, BONE JDS SYNTHES GMBH 2041039 10886982297396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown