BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 14575186 · Received June 2, 2022

    Report

    Report Number
    3004976965-2022-00005
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 5, 2022
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAD INDICATED THE COMPLAINT SAMPLE WAS RETAINED BY THE END CUSTOMER. THUS, THE COMPLAINT SAMPLE WAS NOT RETURNED TO VIANT FOR EVALUATION SO THE REPORTED EVENT IS CONSIDERED NON-VERIFIABLE. THE INSTRUCTIONS FOR USE (IFU) SENT WITH THIS DEVICE TODAY, MAN-000197, STATES THE FOLLOWING; END OF LIFE IS GENERALLY DETERMINED BY WEAR AND DAMAGE DUE TO INTENDED USE. VISUALLY INSPECT FOR DAMAGE AND WEAR. CHECK HINGED INSTRUMENTS FOR SMOOTH MOVEMENT. DISCARD DAMAGED INSTRUMENTS. 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 LIFESPAN WHICH IS GENERALLY 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) WAS REVIEWED AND FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS DEVICE HAD EXPERIENCED APPROXIMATELY 4.08 YEARS OF USE. IT IS UNKNOWN AS TO HOW MANY SURGICAL PROCEDURES (CYCLES) THIS DEVICE HAD EXPERIENCED THROUGHOUT ITS LIFE IN THE FIELD. IF THE COMPLAINT SAMPLE IS RECEIVED BY VIANT, IT WILL BE EVALUATED AND THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A SUPPLEMENTAL MEDWATCH 3500A EMDR WILL BE SUBMITTED AS WELL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE MECHANISM TO UNSCREW THE CUP WAS JAMMED/BENT, WHICH MADE IT DIFFICULT TO REMOVE INSERTER WHEN CUP WAS INSERTED. NO ADVERSE EVENTS NOR PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438629 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC4032078

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male