BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION PRIMARY DISTAL FEMORAL VALGUS ALIGNMENT GUIDE

    MDR report key: 2619404 · Received June 12, 2012

    Report

    Report Number
    MW5025791
    Event Type
    Injury
    Date Received
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    SMITH & NEPHEW
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHAT OCCURRED: THE REUSABLE MEDICAL EQUIPMENT COORD FOR (B)(6) IDENTIFIED THAT A DISTAL CUT FIRST ALIGNMENT GUIDE (DCFAG) HAD A DEFECT WITH BONE FRAGMENTS IN THE ANCHOR TIPS AFTER A COMPLETED PT TOTAL-KNEE SURGERY ON (B)(6). IT WAS IDENTIFIED AFTER SPS REPROCESSED AT THE POINT WHEN THE DCFAG WAS BEING REASSEMBLED. THE TWO DRIVING ANCHOR PINS ON EACH GUIDE, ABOUT 3 - 4 MM IN SIZE, WERE VERIFIED TO CONTAIN IMPACTED BONE. NWI CONTACTED THE DCFAG MFR, SMITH AND NEPHEW FEMORAL INSTRUMENT SETS, SALES REP TO NOTIFY HIM THE PIECE WAS POTENTIALLY DEFECTIVE, AND REQUESTED A REPLACEMENT SET. THE REP BROUGHT A STERILE REPLACEMENT SET. IT WAS PROCESSED THROUGH SPS, AND WAS IDENTIFIED TO HAVE THE SAME DEFECT WITH BONE FRAGMENT PRESENT IN THE SAME STYLE ANCHOR TIPS. THE OLDER VERSION DCFAG'S MFG BY THIS VENDOR WILL NOT BE USED BASED ON CURRENT FINDINGS. THESE DCFAG GUIDES ARE LOANER SETS, WHICH IS A STANDARD PROCESS. THE SETS ARE USED AT MULTIPLE MED FACILITIES THROUGHOUT THE AREA, AND ARE NOT EXCLUSIVE TO THE VAMC. THE NWI CHIEF OF SURGERY CONSULTED WITH THE ORTHOPEDIC SURGEON, WHO INDICATED THAT THE ANCHOR TIP SET IN QUESTION IS OF AN OLDER STYLE THAT IS VULNERABLE TO FRACTURING BECAUSE IT IS A HOLLOW, ROUND COMPOSITION. THIS HOLLOW TIP APPEARS TO BE VULNERABLE TO RETAINING BONE FRAGMENTS. CONSEQUENTLY, NWI WILL IMMEDIATELY CEASE USING THIS OLDER STYLE FOR A NEWER DESIGN THAT HAS A FLAT-BLADE THAT HAS NOT SHOWN VULNERABILITY TO FRACTURING. CONSEQUENTLY, THERE WILL BE NO IMPACT TO CURRENTLY SCHEDULED SURGERIES THAT REQUIRE THIS GUIDE SET. NWI IS ALSO RECOMMENDING THAT VHA INVESTIGATE THE VULNERABILITY OF THE OLDER, HOLLOW TIP DCFAG AND DISCUSS THIS WITH THE MFR, AND CONSIDER DISCONTINUING ITS USE AT OTHER VAMC'S. WHEN I ASKED SMITH AND NEPHEW FOR THE FDA MFR CLEARANCE APPROVAL NUMBER FOR THE LEGION PRIMARY DISTAL FEMORAL VALGUS ALIGNMENT GUIDE PART # (B)(4) A GENESIS II MIS INSTRUMENT, THEY RESPONDED THAT THE DEVICE WAS A US CLASS I INSTRUMENT AND EXEMPT FROM 510 (K) NOTIFICATION. I'M CONCERNED THAT A DEVICE USED FOR AN INVASIVE PROCEDURE IS NOT IN A HIGHER CLASS. THIS DEVICE IS RETAINING BONE FRAGMENTS EVEN FOLLOWING SPS CLEANING AT TWO SEPARATE FACILITIES WHO USE THIS VENDOR FOR REUSABLE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGION PRIMARY DISTAL FEMORAL VALGUS ALIGNMENT GUIDE DISTAL CUT FIRST ALIGNMENT GUIDE JWH SMITH & NEPHEW PART #7144-1144

    Patients

    Seq Age Sex Outcome Treatment
    1