BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 23415953 · Received October 29, 2025

    Report

    Report Number
    3004976965-2025-00012
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 1, 2025
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096400076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE COMPLAINT SAMPLE WAS NOT RETURNED TO VIANT FOR EVALUATION. THUS, THE REPORTED EVENT IS NON-VERIFIABLE. THE CURRENT IFU SENT WITH THIS DEVICE TODAY, MAN-004006 REV. A, STATES THE FOLLOWING: END OF LIFE IS DETERMINED BY WEAR AND DAMAGE DUE TO INTENDED USE. VISUALLY INSPECT FOR DAMAGE AND WEAR. IF THE INSTRUMENT IS DAMAGED AND WORN IT IS CONSIDERED AT THE END OF ITS LIFE AND SHOULD BE DISCARDED. WHERE INSTRUMENTS FORM PART OF A LARGER ASSEMBLY, CHECK ASSEMBLY WITH MATING COMPONENTS. VIANT DEVICES SHOULD ONLY BE USED BY QUALIFIED PERSONNEL FULLY TRAINED IN THE USE OF THE SURGICAL INSTRUMENTS AND THE RELEVANT SURGICAL PROCEDURES. DO NOT MODIFY VIANT INSTRUMENTS IN ANY WAY AND HANDLE WITH CARE AT ALL TIMES. SURFACE SCRATCHES CAN INCREASE WEAR AND THE RISK OF CORROSION. MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE-SPAN WHICH IS DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. WHEN A SURGICAL INSTRUMENT REACHES THE END OF ITS FUNCTIONAL LIFE, CLEAN THE INSTRUMENT OF ANY AND ALL BIOMATERIAL/BIOHAZARDS AND SAFELY DISCARD THE INSTRUMENT IN ACCORDANCE WITH APPLICABLE LAWS AND REGULATIONS. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS DEVICE HAS EXPERIENCED APPROXIMATELY 4.87 YEARS OF USE. THE VIANT RISK MANAGEMENT FILES WERE REVIEWED TO ENSURE THE REPORTED FAILURE MODE (OR SIMILAR) IS CAPTURED AND ASSESSED. THE REVIEW REVEALED THERE ARE SIMILAR FAILURE MODES IDENTIFIED AND MITIGATED TO THE LOWEST POSSIBLE RISK REGION. IN CONCLUSION, THE COMPLAINT SAMPLE WAS NOT RECEIVED BY VIANT FOR EVALUATION AND THE REPORTED EVENT IS NON-VERIFIABLE. IF THE COMPLAINT SAMPLE IS RECEIVED BY VIANT, IT WILL BE EVALUATED AND THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED AT THIS TIME. VIANT WILL CONTINUE TO MONITOR FOR TRENDS. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, DEPUY SYNTHES.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE CONNECTION POINT HAS WORN DOWN AND THE SHAFT IS WOBBLING WITH USE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720145 VIANT MEDICAL, LLC STRAIGHT REAMER HANDLE LXH VIANT MEDICAL, LLC T17652 PC5044137 00840096400076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown