BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOS CARPAL TUNNEL RELEASE SYS

    MDR report key: 4368886 · Received December 10, 2014

    Report

    Report Number
    3008792617-2014-00001
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    December 9, 2014
    Manufacturer
    THAYER INTELLECTUAL PROPERTY INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A QUAL INSPECTION STEP SPECIFICALLY ASSESSES THE INTEGRITY OF THE PROBE COMPONENTS. AS A PREVENTATIVE MEASURE, AN ADDITIONAL WARNING HAS BEEN ADDED TO THE INSTRUCTIONS FOR USE WARNING AGAINST REUSE AND SEVERE BENDING OF THE INSTRUMENT.

    Description of Event or Problem · 1

    THE MANOS CARPAL TUNNEL RELEASE SYS WAS USED IN A CARPAL TUNNEL RELEASE PROCEDURE. DURING THE COURSE OF THE PROCEDURE, THE PHYSICIAN REMOVED THE PROBE WIRE, MANUALLY MANIPULATED A BENT INTO THE PROBE WIRE, REINSERTED AND CONTINUED THE PROCEDURE TO COMPLETION. THE PROBE BROKE DURING USE, COMPONENTS WERE WITHDRAWN. THE PT COMPLAINED OF RESIDUAL PAIN IN HER HAND. APPROXIMATELY 2 WEEKS LATER, THE PHYSICIAN ORDERED AN X-RAY WHICH DETECTED A PIECE OF THE PROBE ASSEMBLY IN THE PT'S HAND. EXPLORATORY SURGERY APPROXIMATELY 4 WEEKS FROM THE CARPAL TUNNEL RELEASE SURGERY THE BROKEN PROBE COMPONENT WAS REMOVED. THE SURGERY ALSO REVEALED AN ABRADED TENDON. THE PHYSICIAN SUCCESSFULLY REPAIRED THE TENDON DURING THIS SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797831 MANOS CARPAL TUNNEL RELEASE SYS MANOS CARPAL TUNNEL RELEASE BLADE HRX THAYER INTELLECTUAL PROPERTY INC. TY-12-101 918240

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention