BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 22886282 · Received August 25, 2025

    Report

    Report Number
    3004976965-2025-00010
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 7, 2025
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096401752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. CHECK HINGED INSTRUMENTS FOR SMOOTH MOVEMENT. EACH COMPONENT OF THE VIANT OFFSET REAMER HANDLE IS NOT A MEDICAL DEVICE, ALL COMPONENTS WHEN ASSEMBLED CREATE THE MEDICAL DEVICE. THEREFORE, THE COMPONENTS OF EACH VIANT REAMER HANDLE FORM A UNIQUE SET WHEN ASSEMBLED. IN NO INSTANCE SHOULD THE COMPONENTS FROM ONE OFFSET REAMER HANDLE BE MIXED WITH COMPONENTS FROM ANOTHER REAMER HANDLE. THE UNIQUE DEVICE IDENTIFICATION FOR THIS MEDICAL DEVICE IS LOCATED ON THE ASSEMBLED OFFSET REAMER HANDLE. 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 RECORD (DHR) REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE VIANT RISK MANAGEMENT FILES WERE REVIEWED TO ENSURE THE REPORTED FAILURE MODE AND RISK (OR SIMILAR) IS CAPTURED AND ASSESSED. THE REVIEW REVEALED THERE ARE SIMILAR FAILURE MODES AND RISKS 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. B1, B2, B5, H1: NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION. THE EVENT IS BEING REPORTED DUE TO THE RISK OF POTENTIAL USER/PATIENT INJURY OR INFECTION OCCURRING AND NOT THE MALFUNCTION. THERE HAVE BEEN NO SIMILAR ADVERSE EVENTS REPORTED THAT HAD LED TO DEATH OR SERIOUS INJURY. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, ZIMMER BIOMET. COMPLAINT SOURCE IS FOREIGN AS THE EVENT OCCURRED IN CANADA.

    Additional Manufacturer Narrative · 0

    H2, H3: THE COMPLAINT SAMPLE WAS RETURNED TO VIANT FOR EVALUATION AND THE REPORTED EVENT IS CONFIRMED. THE DRIVE CHAIN FRACTURED AT THE UNIVERSAL JOINTS (UJ) DUE TO PRODUCT END OF LIFE. THE DEVICE WAS RETURNED TO VIANT ASSEMBLED. ONCE DISASSEMBLED, IT WAS EVIDENT THE DRIVE CHAIN HAD FRACTURED ON THE PROXIMAL UJ. THE PROXIMAL UJ HAS FRACTURED AT THE FORK AND BLOCK. THE UJ HAS OBVIOUS SIGNS OF SIGNIFICANT WEAR ON THE FORKS AND BLOCK. THE BLOCK IS ERODED COMPLETELY ON BOTH SIDES OF THE PROXIMAL UJ AND ONE OF THE FORKS IS CRACKED THROUGH THE WELD. THE DISTAL UJ FORKS AND BLOCK ARE ALSO SIGNIFICANTLY WORN WITH A SIMILAR CRACK OF THE FORK THROUGH THE WELD. IT IS THE WORN/ERODED SURFACE OF THE FORK WHICH IS THE SUSPECTED CAUSE OF THE REPORTED EVENT. THE UJ FORK WAS WORN TO AN EXTENT THAT THE SURFACE HAD NEARLY CREATED A SHARP EDGE. HOWEVER, WHEN TESTED WITH GLOVES WORN DURING EXAMINATION AND FINGERS RAN SPECIFICALLY THROUGH THIS AREA, THERE WAS NO CUTTING OF THE GLOVES. BASED ON THE WEAR AND DAMAGE OBSERVED ON THE DRIVE CHAIN, IT HAS FAR EXCEEDED ITS EXPECTED USEFUL LIFE (END OF LIFE) FROM PROLONGED USE AND SHOULD HAD BEEN DISCARDED LONG PRIOR TO USE THAT LEAD TO THE REPORTED COMPLAINT. THE RETURNED OFFSET REAMER HANDLE ASSEMBLY WAS ALSO MIXED WITH COMPONENTS FROM OTHER REAMER HANDLES (DIFFERENT LOT NUMBERS). INDEX HANDLE: LOT: "56467986", AGED 20.38 YEARS. Z-TUBES: LOT: "56468165", AGED 20.34 YEARS. DRIVE CHAIN: LOT: "56596613", AGED 6.92 YEARS. THE COMPONENTS OF EACH VIANT OFFSET REAMER HANDLE FORM A UNIQUE SET WHEN ASSEMBLED. IN NO INSTANCE SHOULD THE COMPONENTS FROM ONE REAMER HANDLE BE MIXED WITH COMPONENTS FROM ANOTHER DEVICE AS INSTRUCTED BY THE CURRENT IFUS SENT WITH THIS DEVICE, MAN-004006 & MAN-004018. OTHER OBSERVATIONS INCLUDE OBSERVABLE WEAR AND DAMAGE ON THE Z-TUBES AND POWER ADAPTOR. 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, EACH COMPONENT OF THE VIANT OFFSET REAMER HANDLE IS NOT A MEDICAL DEVICE, ALL COMPONENTS WHEN ASSEMBLED CREATE THE MEDICAL DEVICE. THEREFORE, THE COMPONENTS OF EACH VIANT REAMER HANDLE FORM A UNIQUE SET WHEN ASSEMBLED. IN NO INSTANCE SHOULD THE COMPONENTS FROM ONE OFFSET REAMER HANDLE BE MIXED WITH COMPONENTS FROM ANOTHER REAMER HANDLE. THE UNIQUE DEVICE IDENTIFICATION FOR THIS MEDICAL DEVICE IS LOCATED ON THE ASSEMBLED OFFSET REAMER HANDLE, 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 DRIVE CHAIN HAS EXPERIENCED APPROXIMATELY 6.92 YEARS OF USE. IT IS UNKNOWN AS TO HOW MANY SURGICAL PROCEDURES (CYCLES) THIS DEVICE HAD EXPERIENCED THROUGHOUT ITS LIFE IN THE FIELD. THE VIANT RISK MANAGEMENT FILES WERE REVIEWED AND IDENTIFIED SIMILAR FAILURE MODES TO THE OBSERVED FAILURE. FROM THE TREND ANALYSIS PERFORMED, THE ESTIMATED FAILURE RATE FALLS WITHIN THE OCCURRENCE RATE IDENTIFIED IN THE VIANT RISK MANAGEMENT FILES. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE RETURNED OFFSET REAMER HANDLE WAS FRACTURED AT THE DRIVE CHAIN UJ FROM SIGNIFICANT WEAR DUE TO PRODUCT END OF LIFE. FROM THE INVESTIGATION PERFORMED, THE ROOT CAUSE IS ATTRIBUTED TO WEAR (USED BEYOND EXPECTED USEFUL LIFE) AS THE DEVICE HAD FAR EXCEEDED ITS EXPECTED USEFUL LIFE AND SHOULD HAD BEEN DISCARDED LONG PRIOR TO USE THAT LEAD TO THE REPORTED COMPLAINT. SECONDARY ROOT CAUSE IS MISUSE (MIXED PRODUCT, PROLONGED USE) AS THE RETURNED ASSEMBLY IS MIXED WITH COMPONENTS FROM MULTIPLE REAMER HANDLES. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. VIANT WILL CONTINUE TO MONITOR FOR TRENDS. D9, G3, H2: ADDED DATE DEVICE RETURNED TO MANUFACTURER. D4: ADDED DEVICE INFORMATION (LOT NUMBER). H6: UPDATED COMPONENT, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & CONCLUSIONS CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OFFSET REAMER IS WORN ON THE METALLIC SIDE, SO WHEN THE NURSE OR SURGEON USE IT, THERE IS RISK OF CUTTING THE GLOVE AND THEY NEED TO CHANGE GLOVES TO USE IT. THERE IS CONCERN THAT IF THEY CUT THE GLOVE THERE IS RISK TOO INFECT THE USER OR PATIENT. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511764 VIANT MEDICAL, LLC OFFSET REAMER HANDLE LXH VIANT MEDICAL, LLC T5766 56596613 00840096401752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other