BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET REAMER HANDLE

    MDR report key: 19320402 · Received May 15, 2024

    Report

    Report Number
    3004976965-2024-00009
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 17, 2024
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096400083
    Product Problem
    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 BUT THE CUSTOMER PROVIDED AN IMAGE. HOWEVER, THE PROVIDED IMAGE IS INSUFFICIENT TO VERIFY THE REPORTED FAILURE. THUS, THE REPORTED EVENT IS NON-VERIFIABLE. THE CUSTOMER PROVIDED IMAGE SHOWS ONLY THE INDEX HANDLE TUBE OF THE OFFSET REAMER HANDLE ASSEMBLY WITH THE PRODUCT IDENTIFIERS. THE DRIVE CHAIN AND BOTH Z-TUBES OF THE OFFSET REAMER HANDLE ASSEMBLY IS NOT VISIBLE. THERE IS NO OBVIOUS FAILURE OR DAMAGE OBSERVED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE BASED ON THIS IMAGE. 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 FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. CHAIN ASSEMBLY OPERATION 800 (FINAL INSPECTION) FUNCTION TESTED AT 100% FREQUENCY AND ALL 48 UNITS PASSED. OFFSET REAMER HANDLE ASSEMBLY OPERATION 800 (FINAL INSPECTION) FUNCTION, ASSEMBLY, VISUAL INSPECTION PER OFFSET REAMER HANDLE WORK INSTRUCTIONS AT 100% FREQUENCY AND ALL 48 UNITS PASSED. FINISHED OFFSET REAMER HANDLE OPERATION 60 (ASSEMBLY) & 800 (FINAL INSPECTION) FUNCTION TESTED TO ACTUATE DEVICE, MUST SPIN FREELY AT 100% FREQUENCY AND ALL 48 UNITS PASSED. BASED ON THE LOT NUMBER, THE DEVICE HAD EXPERIENCED APPROXIMATELY 1.42 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 THE FAILURE MODES WERE IDENTIFIED AND MITIGATED TO THE LOWEST POSSIBLE LEVEL. IN CONCLUSION, THE REPORTED EVENT IS NON-VERIFIABLE AS THE PROVIDED IMAGE OF THE INDEX HANDLE TUBE OF THE OFFSET REAMER HANDLE ASSEMBLY SHOW NO OBVIOUS FAILURE OR DAMAGE THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE BASED ON THE IMAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE DEVICE IS WOBBLING IN THE DRILL CHUCK. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482847 OFFSET REAMER HANDLE OFFSET REAMER HANDLE LXH VIANT MEDICAL, LLC T17653 PC5470404-35 00840096400083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown