BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPAL TUNNEL ECTR BLADE ASSEMBLY

    MDR report key: 11649205 · Received April 12, 2021

    Report

    Report Number
    2134070-2021-00007
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 18, 2021
    Report Date
    March 18, 2021
    Manufacturer
    STERILMED, INC.
    Product Code
    LXH
    UDI-DI
    10888551001953
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE ENDOSCOPIC BLADE BROKE INSIDE THE PATIENT. WE COULD NOT CONFIRM THE REPORTED ISSUE BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RECEIVED FOR EVALUATION AND COULD NOT BE VERIFIED AS BEING A STERILMED REPROCESSED DEVICE. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR THE FINISHED DEVICE LOT 2093460 AND NO NONCONFORMANCES WERE IDENTIFIED. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED CARPAL TUNNEL ECTR BLADE ASSEMBLY AND THE ENDOSCOPIC BLADE BROKE INSIDE THE PATIENT. THERE WAS NO DIFFICULTY, PROCEDURAL OR PATIENT CIRCUMSTANCE IDENTIFIED BEFORE THE BREAK THAT CONTRIBUTED TO THE ISSUE REPORTED. THE FRAGMENTS WERE REMOVED FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS REQUIRED. HOWEVER, ADDITIONAL TIME WAS NEEDED AS THERE WAS SOME DIFFICULTY FINDING THE BROKEN PIECES INSIDE OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551375 CARPAL TUNNEL ECTR BLADE ASSEMBLY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STERILMED, INC. MIC81010 2093460 10888551001953

    Patients

    Seq Age Sex Outcome Treatment
    1