BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 20921978 · Received December 13, 2024

    Report

    Report Number
    3004976965-2024-00023
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 10, 2025
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    HTO
    UDI-DI
    00840096400557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2: THE COMPLAINT SAMPLE WAS NOT RETURNED TO VIANT FOR EVALUATION AND SO THE REPORTED EVENT IS NON-VERIFIABLE. WORN REAMERS WILL BECOME LESS EFFECTIVE OVER TIME AND WILL REQUIRE ADDITIONAL FORCES TO REAM CORRECTLY, CAUSING ADDITIONAL STRESS ON THE WELDED EDGES OF THE CROSSBARS. THESE ADDED FORCES CAN LEAD TO ADDITIONAL FAILURES. THE INFORMATION PROVIDED INDICATES THE REAMER WAS ALREADY DULL PRIOR TO WHEN THE IMPLANT CUP COULD NOT BE PROPERLY SEATED. THIS CONTINUED USE OF THE DULL REAMER REQUIRED ADDITIONAL REAMING AND FORCE. THIS CLEARLY SUGGESTS USER ERROR CONTRIBUTED TO THE EVENT. THE CURRENT IFU SENT WITH THIS DEVICE TODAY, (B)(4) REV. A, STATES THE FOLLOWING. · ORTHOPEDIC MEDICAL DEVICES ARE RE-USABLE INSTRUMENTS USED IN A CLINICAL SETTING FOR ORTHOPEDIC SURGERY. · ANTICIPATED USEFUL LIFE: 60 USE CYCLES. · REPEATED PROCESSING HAS MINIMAL EFFECT ON THESE INSTRUMENTS. END OF LIFE IS DETERMINED BY WEAR AND DAMAGE DUE TO INTENDED USE. · VISUALLY INSPECT FOR DAMAGE AND WEAR. CUTTING EDGES SHOULD BE FREE OF NICKS AND PRESENT A CONTINUOUS EDGE. IF THE INSTRUMENT IS DAMAGED AND WORN IT IS CONSIDERED AT THE END OF ITS LIFE AND SHOULD BE DISCARDED. · WHEN UDI CARRIER(S) IS NO LONGER READABLE, THE INSTRUMENT IS TO BE DISCARDED. · 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 REAMER HAD EXPERIENCED THROUGHOUT ITS LIFE IN THE FIELD. THE VIANT RISK MANAGEMENT FILES WERE REVIEWED TO ENSURE THE REPORTED FAILURE MODE (OR SIMILAR) IS CAPTURED AND ASSESSED. THE REVIEW REVEALED THERE ARE SIMILAR FAILURE MODES IDENTIFIED AND MITIGATED TO THE LOWEST POSSIBLE RISK REGION. IN CONCLUSION, THE COMPLAINT SAMPLE WAS NOT RETURNED TO VIANT FOR EVALUATION AND SO THE REPORTED EVENT IS NON-VERIFIABLE. IF THE COMPLAINT SAMPLE IS RETURNED TO VIANT, IT WILL BE EVALUATED AND THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. VIANT WILL CONTINUE TO MONITOR FOR TRENDS. H6: UPDATED INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS BASED ON EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: THE CUSTOMER HAS INDICATED THE COMPLAINT SAMPLE WILL NOT BE RETURNED TO VIANT FOR EVALUATION. VIANT WILL CONTINUE TO PURSUE ADDITIONAL INFORMATION SUCH AS THE LOT NUMBER AND FURTHER CLARIFICATION TO BETTER ASSIS IN THE EVALUATION. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP MEDWATCH 3500A EMDR WILL BE SUBMITTED. B4,G3: ORIGINAL NOTIFICATION OF THE MALFUNCTION WAS RECEIVED ON 30-OCT-2024. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 12-NOV-2024, LEADING TO THE DECISION TO INITIATE A MDR. B5,C5,H6: THERE WERE NO ADVERSE EVENTS NOR PATIENT CONSEQUENCES RESULTING FROM THE MALFUNCTION. ADDITIONALLY, THERE HAVE BEEN NO SIMILAR EVENTS WITHIN THIS PRODUCT FAMILY THAT HAS RESULTED IN DEATH OR SERIOUS INJURY. ALTHOUGH THERE WERE NO REPORTED DEATH OR SERIOUS INJURIES ASSOCIATED WITH THIS EVENT (AND SIMILAR OCCURRENCES) AND THE APPARENT USER ERROR (SPECIFICALLY THE CONTINUED USE OF A DULL REAMER), IT WAS INDICATED ADDITIONAL REAMING AND FORCE WERE REQUIRED WHEN THE IMPLANT CUP COULD NOT BE PROPERLY SEATED. THEREFORE, VIANT HAS DECIDED TO REPORT THIS SINGLE EVENT. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A 76 YEAR OLD FEMALE PATIENT THAT THE REAMER WAS DULL. ADDITIONAL INFORMATION RECEIVED LATER INDICATED THE MALFUNCTION OCCURRED WHILE REAMING THE ACETABULUM AND THE CUP WOULD NOT SEAT. THEREFORE, THE CUP WAS TAKEN OUT TO REAM AGAIN PRESSING HARDER INTO THE ACETABULUM. THERE WAS A SLIGHT SURGICAL DELAY (COUPLE OF MINUTES) WITH NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936926 VIANT MEDICAL, LLC CROSSBACK ACETABULAR REAMER 48 MM HTO VIANT MEDICAL, LLC T17617 00840096400557

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female