BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFEX ARTHROSCOPY HOOK

    MDR report key: 34526 · Received July 19, 1996

    Report

    Report Number
    34526
    Event Type
    Injury
    Date Received
    July 19, 1996
    Date of Event
    July 16, 1996
    Report Date
    July 18, 1996
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING LEFT KNEE SURGERY. WHILE USING THE HOOK KNIFE IN THE PT'S LEFT KNEE, THE INSTRUMENT BROKE INTO 3 PIECES. TWO (2) PIECES WERE IN PT'S KNEE, AND THE DR REMOVED THEM AND PROCEEDED WITH THE PROCEDURE. NO APPARENT RESIDUAL NEGATIVE OUTCOME TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX ARTHROSCOPY HOOK ARTHROSCOPY 3MM HOOK HRX SMITH & NEPHEW ENDOSCOPY, INC. 010168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention