BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANT MEDICAL, LLC

    MDR report key: 19827225 · Received July 25, 2024

    Report

    Report Number
    3004976965-2024-00016
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 21, 2024
    Report Date
    December 12, 2024
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    LXH
    UDI-DI
    00840096401394
    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 BUT THE CUSTOMER PROVIDED AN IMAGE. HOWEVER, THE IMAGE IS INSUFFICIENT TO VERIFY THE REPORTED FAILURE. THUS, THE REPORTED EVENT IS NON-VERIFIABLE. THE CUSTOMER PROVIDED IMAGE SHOWS STRAIGHT REAMER HANDLE DISASSEMBLED ALONG WITH THE TEFLON SLEEVE SLIGHTLY DISASSEMBLED. THE PRODUCT IDENTIFIERS AREN'T VISIBLE. THE IMAGE IS ALSO OUT OF FOCUS AS THE DEVICE APPEARS TO BE BLURRY. 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, · 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 2.65 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 REPORTED EVENT IS NON-VERIFIABLE AS THE PROVIDED IMAGE OF THE STRAIGHT REAMER HANDLE SHOWS NO OBVIOUS FAILURE OR DAMAGE OBSERVED 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. D4,H2: CORRECTED LOT NUMBER FROM CUSTOMER TO VIANT LOT NUMBER. D9,G3,H2: ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER INDICATING ALL PRODUCT RETURNS FROM CANADA ARE ON HOLD, NO UPDATE HAS BEEN PROVIDED FROM CANADA REGARDING PRODUCT RETURNS, AND TO MOVE FORWARD WITH THE INVESTIGATION WITHOUT THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS INDICATED 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. G2: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, ZIMMER BIOMET. COMPLAINT SOURCE IS FOREIGN AS EVENT OCCURRED IN CANADA.

    Additional Manufacturer Narrative · 0

    H3: THE COMPLAINT SAMPLE WAS RETURNED TO VIANT FOR EVALUATION AND THE REPORTED EVENT IS CONFIRMED. THE STRAIGHT REAMER HANDLE POWER ADAPTOR IS BENT LEADING TO THE REPORTED WOBBLE / ECCENTRIC MOTION. THE STRYKER/ZIMMER-HALL POWER ADAPTOR END WAS OBSERVED TO BE BENT OUT OF PLACE AND DAMAGED WITH SIGNS OF INDENTATIONS FROM PROLONGED REPEATED USE. BENDING OF THIS NATURE WOULD NOT OCCUR DURING NORMAL INTENDED USE AND LIKELY WOULD HAD OCCURRED FROM APPLYING NON-LINEAR LOAD (OFF-AXIS FORCE APPLIED). THUS, THE COMPLAINT SAMPLE HAD BEEN MISUSED. IT IS UNKNOWN WHAT ADAPTOR OR POWER SOURCE (NEITHER PROVIDED BY VIANT) WAS CONNECTED TO THE DEVICE. THE DEVICE WAS PLACED UNDER POWER TO SIMULATE USE AND WOBBLING (ECCENTRIC MOTION) WAS OBSERVED DUE TO THE OBSERVED FAILURES ON THE STRYKER/ZIMMER-HALL POWER ADAPTOR END. 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, · 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 0.91 YEARS OF USE. IT IS UNKNOWN HOW MANY SURGICAL PROCEDURES (CYCLES) THIS DEVICE HAS 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. A TREND ANALYSIS WAS PERFORMED AND SIMILAR COMPLAINTS WERE ATTRIBUTED TO MISUSE (OFF-AXIS FORCE). THE TREND ANALYSIS REVEALS THE ESTIMATED FAILURE RATE FALLS WITHIN THE OCCURRENCE RANGE IDENTIFIED IN THE VIANT RISK MANAGEMENT FILES. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE RETURNED STRAIGHT REAMER HANDLE POWER ADAPTOR IS BENT LEADING TO THE REPORTED WOBBLE / ECCENTRIC MOTION. FROM THE INVESTIGATION PERFORMED, THE ROOT CAUSE ATTRIBUTED TO THE REPORTED EVENT IS MISUSE (UNINTENDED USE) AS BENDING OF THIS NATURE WOULD NOT OCCUR DURING NORMAL INTENDED USE AND LIKELY WOULD HAD OCCURRED FROM APPLYING NON-LINEAR LOAD (OFF-AXIS FORCE APPLIED). 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 A THA PROCEDURE ON THE RIGHT SIDE OF AN UNKNOWN PATIENT THAT THE THE SHAFT DOES NOT REAM IN A CIRCULAR FASHION AND REAMS OFF CENTER. THERE WAS A DELAY OF FIVE MINUTES TO OPEN ANOTHER SIMILAR DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354437 VIANT MEDICAL, LLC EZ CLEAN¿ REAMER HANDLE LXH VIANT MEDICAL, LLC T2756 5580681 00840096401394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown