BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 22136395 · Received June 3, 2025

    Report

    Report Number
    3004976965-2025-00006
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 1, 2025
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096401394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE COMPLAINT DEVICE HAS BEEN RETURNED TO VIANT BUT HAS YET TO BE EVALUATED. ONCE THE COMPLAINT DEVICE IS EVALUATED, A FOLLOW-UP MEDWATCH 3500A EMDR WILL BE SUBMITTED. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, (B)(4).

    Additional Manufacturer Narrative · 0

    H3: THE COMPLAINT SAMPLE WAS RETURNED TO VIANT FOR EVALUATION AND THE REPORTED EVENT IS CONFIRMED. THE STRAIGHT REAMER HANDLE POWER ADAPTOR IS BENT LEADING TO THE REPORTED WOBBLE. THE STRYKER/ZIMMER-HALL POWER ADAPTOR END WAS OBSERVED TO BE BENT OUT OF PLACE. A BENT/DEFORMED POWER ADAPTOR CAUSES A NON-LINEAR (ECCENTRIC) REAMING MOTION OF THE DEVICE WHEN CONNECTED AND POWERED BY THE SURGICAL DRILL. BENDING OF THIS NATURE WOULD NOT OCCUR DURING NORMAL INTENDED USE AND LIKELY WOULD HAD OCCURRED FROM APPLYING NON-LINEAR LOAD (OFF-AXIS FORCE APPLIED). THUS, THE COMPLAINT SAMPLE HAD BEEN MISUSED. IT IS UNKNOWN WHAT ADAPTOR OR POWER SOURCE (NEITHER PROVIDED BY VIANT) WAS CONNECTED TO THE DEVICE. 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 2.49 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 STRAIGHT REAMER HANDLE POWER ADAPTOR IS BENT LEADING TO THE REPORTED WOBBLE. FROM THE INVESTIGATION PERFORMED, THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR (MISUSE) AS BENDING OF THIS NATURE WOULD NOT OCCUR DURING NORMAL INTENDED USE AND LIKELY WOULD HAD OCCURRED FROM APPLYING NON-LINEAR LOAD (OFF-AXIS FORCE APPLIED). NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. VIANT WILL CONTINUE TO MONITOR FOR TRENDS. H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND CONCLUSIONS CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE REAMER HANDLE WAS WOBBLY ON THE HUDSON ADAPTER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358273 VIANT MEDICAL, LLC EZ CLEAN¿ REAMER HANDLE LXH VIANT MEDICAL, LLC T2756 56596909 00840096401394

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male