BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFEX

    MDR report key: 82828 · Received April 4, 1997

    Report

    Report Number
    82828
    Event Type
    Malfunction
    Date Received
    April 4, 1997
    Date of Event
    March 6, 1997
    Report Date
    March 6, 1997
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    KDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING MOSAIC CARTILAGE TRANSPLANT OF LEFT KNEE, 3.5MM CHISEL BROKE & PORTION LODGED IN PT'S KNEE (PATELLA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFEX TUBULAR CHISEL KDG SMITH & NEPHEW ENDOSCOPY 3.5MM(L196) *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR