BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 20592524 · Received November 1, 2024

    Report

    Report Number
    3004976965-2024-00022
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 26, 2024
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    HWA
    UDI-DI
    00840096400045
    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. THUS, THE REPORTED EVENT IS NON-VERIFIABLE. THE IFU SENT WITH THIS DEVICE TODAY, MAN-004011 REV B, STATES THE FOLLOWING; OFFSET CUP IMPACTORS ARE HAND-HELD, RE-USABLE SURGICAL INSTRUMENTS. ANTICIPATED USEFUL LIFE OFFSET CUP IMPACTOR: 600 USE CYCLES, 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, CHECK HINGED INSTRUMENTS FOR SMOOTH MOVEMENT, WHEN THE 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 RECORDS (DHR) WERE REVIEWED AND FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS DEVICE HAS EXPERIENCED APPROXIMATELY 6.03 YEARS OF USE. 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 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. H6: UPDATED TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS BASED ON EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: THE CUSTOMER HAS NOT INDICATED IF THE COMPLAINT SAMPLE WILL BE RETURNED TO VIANT FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED TO DATE. ONCE THE COMPLAINT SAMPLE IS RECEIVED, IT WILL BE INVESTIGATED AND A FOLLOW-UP MEDWATCH 3500A EMDR WILL BE SUBMITTED. D4: PRIMARY UDI# PROVIDED IS THE CURRENT VIANT MEDICAL UDI-DI FOR MODEL NUMBER: 511172. THE ADDITIONAL UDI# PROVIDED IS THE LEGACY GREATBATCH MEDICAL UDI-DI FOR MODEL NUMBER: 511172 PRIOR TO VIANT MEDICAL ACQUISITION OF THE PRODUCT. THIS LOT NUMBER WAS MANUFACTURED IN 2018 BY GREATBATCH MEDICAL. VIANT MEDICAL ACQUIRED THIS PRODUCT LINE FROM GREATBATCH MEDICAL (SUBSIDIARY OF INTEGER HOLDINGS) IN 2018. THEREFORE, THE LEGACY UDI-DI# IS PROVIDED AS THE ADDITIONAL UDI# AND THE CURRENT UDI-DI# IS PROVIDED AS THE PRIMARY UDI#. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, DEPUY SYNTHES.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A MALE PATIENT THAT THE HANDLE WOULDN'T DISENGAGE FROM THE CUP ONCE THE CUP WAS PLACED. NO KNOWN DELAY AND CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188718 VIANT MEDICAL, LLC METAL HANDLE OFFSET CUP IMPACTOR HWA VIANT MEDICAL, LLC 511172 PC4194847 00840096400045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male