BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA GUIDE CTR SONNEX KNIFE

    MDR report key: 18884978 · Received March 8, 2024

    Report

    Report Number
    MW5152601
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 6, 2024
    Manufacturer
    SONEX HEALTH, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS A 75-YEAR-OLD MALE PATIENT WHO PRESENTED TO (B)(6) ON (B)(6) 2024 FOR AN ULTRASOUND GUIDANCE CARPAL TUNNEL RELEASE USING AN ULTRA GUIDE CTX SONNEX KNIFE. THE OPERATIVE REPORT STATES THAT AN 11-SCALPEL BLADE WAS USED TO CREATE A 4- 5 MM MINI OPEN INCISION UNDER STERILE TECHNIQUE. DIRECT ULTRASOUND GUIDANCE WAS THEN USED TO PASS THE DEVICE INTO THE CARPAL TUNNEL AND POSITION IT WITHIN THE TRANSVERSE AND LONGITUDINAL SAFE ZONES. THE CUTTING KNIFE WAS PLACED IN ITS DISTAL RECESSED POSITION, THE BALLOONS DEFLATED AND THE TRANSVERSE CARPAL LIGAMENT PROBED USING THE STAINLESS-STEEL DILATOR TO ENSURE COMPLETE LIGAMENT TRANSECTION AND RELEASE OF THE MEDIAN NERVE FROM THE LIGAMENT AND ADJACENT SYNOVIAL OR SCAR TISSUE. THE DEVICE REMAINED RETRACTED AND UNABLE TO CLOSE (THE KNIFE DID NOT HIDE BACK). THE DEVICE WAS REMOVED CAREFULLY FOR THE INCISION SITE, INSPECTED, AND CONFIRMED INTACT. ON (B)(6) 2024 THE PATIENT WAS SEEN BY THE SURGEON DURING AN OFFICE VISIT. PER SURGEON, THE PATIENT'S CONDITION IMPROVED, NO NERVE DAMAGE OR BLEEDING WAS NOTED. THE NUMBNESS AND TINGLING HAVE IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957100 ULTRA GUIDE CTR SONNEX KNIFE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SONEX HEALTH, INC. 600112-001 61861

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other