BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOS CARPAL TUNNEL RELEASE SYSTEM

    MDR report key: 2427766 · Received January 20, 2012

    Report

    Report Number
    3008792617-2011-00001
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    September 1, 2011
    Report Date
    December 20, 2011
    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. ALTHOUGH A QUALITY INSP STEP SPECIFICALLY ASSESSES THE INTEGRITY OF THE HANDLE, AS A PREVENTIVE MEASURE, THE HANDLE HALVES ARE NOW SECURED WITH ADHESIVE.

    Description of Event or Problem · 1

    THE MANOS CARPAL TUNNEL RELEASE BLADE WAS USED IN A CARPAL TUNNEL RELEASE PROCEDURE. WHEN THE PHYSICIAN DEPLOYED THE RELEASE BLADE, THE HANDLE OF THE DEVICE SEPARATED. THE INSTRUMENT WAS DISCARDED AND A SECOND MANOS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT SUBSEQUENTLY REPORTED A PARESTHESIA OF THE SURFACE OF THE OPERATED HAND. A F/U EXPLORATORY SURGERY REVEALED THE MEDIAN NERVE HAD BEEN ABRADED. THE PHYSICIAN PLACED A SLEEVE AROUND THE NERVE TO AID IN HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANOS CARPAL TUNNEL RELEASE SYSTEM CARPAL TUNNEL RELEASE BLADE HRX THAYER INTELLECTUAL PROPERTY INC. TY-10-100 523339

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention