BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROTEK

    MDR report key: 2820921 · Received October 29, 2012

    Report

    Report Number
    MW5027434
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING DR. (B)(6)'S CASE OF AN ASSISTED ARTHROSCOPIC RIGHT KNEE ACL RECONSTRUCTION, A PIECE OF AN ARTHROTEK ARTHROSCOPIC SUTURE GRASPER BROKE INSIDE PATIENT'S RIGHT KNEE. PIECE WAS RETRIEVED AND MATCHED COMPLETED TO SUTURE GRASPER. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK ARTHROSCOPIC SUTURE GRASPER HRX 902075

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR