BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 23096942 · Received September 19, 2025

    Report

    Report Number
    3004976965-2025-00011
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 22, 2025
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096400076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE COMPLAINT SAMPLE WAS RETURNED INCOMPLETE TO VIANT FOR EVALUATION AND THE REPORTED EVENT IS UNCONFIRMED. THE RETURNED STRAIGHT REAMER HANDLE WAS ABLE TO FUNCTION WITHOUT ISSUE AND EXHIBITS NO FUNCTIONAL FAILURE OR BREAKAGE. THE TEFLON SLEEVE WAS NOT RETURNED WITH THE ASSEMBLY RENDERING THE DEVICE INCOMPLETE AND UNABLE TO BE ASSEMBLED AS INTENDED. AS THE STRAIGHT REAMER HANDLE IS INCOMPLETE AND USED WITHOUT THE TEFLON SLEEVE, THIS IS CONSIDERED MISUSE (USER ERROR) AS THE TEFLON SLEEVE IS REQUIRED TO APPROPRIATELY USE THE DEVICE AS INTENDED. FROM VISUAL EXAMINATION, THE DEVICE WAS ABLE TO BE ASSEMBLE AND FUNCTION WITH EASE. THERE ARE SIGNS OF WEAR AND TEAR FROM REPEATED USE ALONG WITH DAMAGE APPEARING LIKE IMPACT MARKS WHICH IS CONSIDERED MISUSE (NOT INTENDED FOR IMPACT). HOWEVER, THERE IS NO OBSERVED FAILURE OR BREAKAGE. 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, CHECK HINGED INSTRUMENTS FOR SMOOTH MOVEMENT, 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. THE DEVICE HAD EXPERIENCED APPROXIMATELY 6.73 YEARS OF USE. IT IS UNKNOWN AS TO HOW MANY SURGICAL PROCEDURES (CYCLES) THIS DEVICE HAD EXPERIENCED THROUGHOUT ITS LIFE IN THE FIELD. IN CONCLUSION, THE REPORTED EVENT IS UNCONFIRMED AS THE RETURNED STRAIGHT REAMER HANDLE WAS ABLE TO FUNCTION WITHOUT ISSUE AND EXHIBITS NO FUNCTIONAL FAILURE OR BREAKAGE. AS THE STRAIGHT REAMER HANDLE IS INCOMPLETE AND USED WITHOUT THE TEFLON SLEEVE, THIS IS CONSIDERED MISUSE (USER ERROR) AS THE TEFLON SLEEVE IS REQUIRED TO APPROPRIATELY USE THE DEVICE AS INTENDED. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. 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 PROCEDURE ON A FEMALE PATIENT THAT THE REAMER IS SPINNING ELLIPTICALLY. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956680 VIANT MEDICAL, LLC STRAIGHT REAMER HANDLE LXH VIANT MEDICAL, LLC T17652 PC4456017 00840096400076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female