BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE)

    MDR report key: 16968100 · Received May 19, 2023

    Report

    Report Number
    3013479847-2023-00002
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    November 23, 2022
    Report Date
    May 17, 2023
    Manufacturer
    SONEX HEALTH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, THE LOT NUMBER IS UNKNOWN AND THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    ONE PATIENT TREATED WITH ULTRAGUIDECTR WAS DIAGNOSED WITH A PARTIAL THIRD COMMON PALMAR DIGITAL NERVE INJURY AFTER SURGERY, PRESENTING WITH RESOLUTION OF CARPAL TUNNEL SYMPTOMS BUT NEW MID-PALMAR PAIN, PARESTHESIAS, AND INCREASED NUMBNESS IN THE THIRD WEBSPACE. COMPLETE TCL RELEASE WAS CONFIRMED ON POSTOPERATIVE DAY 17 WITH OPEN EXPLORATION, REVEALING AN EPINEURIAL LACERATION WITHOUT AXONAL DISRUPTION ON THE DORSAL ASPECT OF THE THIRD COMMON DIGITAL NERVE, 2 CM DISTAL TO ITS MEDIAN NERVE ORIGIN. A NERVE WRAP WAS PLACED, AND THE INCISION WAS CLOSED WITH SUTURES. AT THE LATEST FOLLOW-UP, CARPAL TUNNEL SYMPTOMS WERE ABSENT, THENAR AND GRIP STRENGTH WERE NORMAL AND SYMMETRICAL, AND SENSATION CONTINUED TO IMPROVE WITH A TWO-POINT DISCRIMINATION OF 6 MM FOR THE ULNAR MIDDLE FINGER, 8 MM FOR THE RADIAL RING FINGER, AND 4 MM FOR THE REMAINING FINGERS. THIS PATIENT'S MID-PALMAR PAIN, PARESTHESIAS, AND INCREASED NUMBNESS IN THE THIRD WEBSPACE HAVE IMPROVED POST-TREATMENT BUT HAVE NOT RESOLVED AT THIS TIME. SYMPTOMS MAY OR MAY NOT BE PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005940 ULTRAGUIDECTR (FORMERLY SX-ONE MICROKNIFE) CARPAL TUNNEL RELEASE SYSTEM LXH SONEX HEALTH 600112-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R