BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM RADIOLUC

    MDR report key: 24363316 · Received February 17, 2026

    Report

    Report Number
    8030965-2026-01538
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    UDI-DI
    10886982297396
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND LATCH OF THE DEVICE IS BROKEN. REMNANTS WERE NOT RETURNED FOR REVISION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. 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, 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 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. DIMENSIONAL INSPECTION: N/A DEVICE HISTORY PART# 03.043.029 SYNTHES LOT# 2024218 SUPPLIER LOT# 2024218 RELEASE TO WAREHOUSE DATE: 03.FEB.2021. SUPPLIER: SYNTHES GMBH. NO NCRS WERE GENERATED DURING PRODUCTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE INSPECTION, THE REPORTER IDENTIFIED DAMAGE TO TWO AIMING ARM INSTRUMENTS. BOTH ITEMS WERE FOUND TO HAVE DAMAGE ON THE CONNECTING HINGES THAT ATTACH TO THE TNA INSERTION HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428372 AIM-ARM RADIOLUC NAIL, FIXATION, BONE JDS SYNTHES GMBH 2024218 10886982297396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown