BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUFEX

    MDR report key: 33415 · Received June 13, 1996

    Report

    Report Number
    MW1009296
    Event Type
    Other
    Date Received
    June 13, 1996
    Date of Event
    May 23, 1996
    Report Date
    June 11, 1996
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY FOR A TORN ACL OF THE LEFT KNEE WITH TORN MEDIAL MENISCUS ON 5/23. DURING PROCEDURE, WHILE USING THE RING CURETTE FROM THE ARTHROSCOPY, THE TIP OF THE RING PORTION OF THE INSTRUMENT BROKE OFF IN THE PT'S LEFT KNEE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP VIA ARTHROSCOPY BUT WAS UNSUCCESSFUL. THERE WAS NO ATTEMPT MADE TO PERFORM OPEN SURGERY TO THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX ARTHROSCOPY CURETTE HRX SMITH & NEPHEW ENDOSCOPY, INC. 012704

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other