BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 23843683 · Received December 18, 2025

    Report

    Report Number
    3004976965-2025-00014
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 13, 2025
    Report Date
    November 21, 2025
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096401783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. HOWEVER, SURGICAL INSTRUMENTS ARE SUSCEPTIBLE TO WEAR AND TEAR, AND THEREFORE SHOULD BE CHECKED FOR DEFECTS BEFORE USE. 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 RECORD (DHR) REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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 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: THERE WERE NO REPORTED HEALTH CONSEQUENCES OR IMPACT. THE EVENT IS BEING REPORTED DUE TO SURGICAL INTERVENTION TO ENSURE REMOVAL OF THE BROKEN TIP WHICH WAS VERIFIED WITH DI IMAGING. THERE HAVE BEEN NO SIMILAR EVENTS FOR THIS PRODUCT FAMILY REPORTED BY VIANT THAT LED TO DEATH OR SERIOUS INJURY. D9, H3: DISTRIBUTOR STATED THE DEVICE IS NOT AVAILABLE. IT WAS DISCARDED BY THE CUSTOMER. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, STRYKER. COMPLAINT SOURCE IS FOREIGN AS THE EVENT OCCURRED IN CANADA.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A LEFT HIP ARTHROPLASTY ON AN UNKNOWN PATIENT THAT THE ACETABULAR REAMER RETAINING TIPS BROKE. 3 OF THE 4 TIPS WERE FOUND IMMEDIATELY BUT THE OTHER WAS NOT. THE AREA WAS THOROUGHLY VISUALLY INVESTIGATED, SUCTION AND IRRIGATION WERE USED TO HELP VIEW THE FIELD, HOWEVER THE REMAINING TIP WAS NOT LOCATED. DI IMAGING WAS PERFORMED AND CONFIRMED THAT THE REMAINING TIP WAS NOT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER POST RADIOGRAPHIC EXAMINATION WITH NO SURGICAL DELAY. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387051 VIANT MEDICAL, LLC ANGLED REAMER HANDLE LXH VIANT MEDICAL, LLC 510012 00840096401783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other