BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUTT LOW PROFILE FORCEPS, STRAIGHT 3.4MM DIA

    MDR report key: 1003764 · Received February 22, 2008

    Report

    Report Number
    1017294-2008-00144
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS INSTRUMENT FOR INVESTIGATION WITHOUT THE BROKEN PIECE. DURING EXAMINATION OF THIS INSTRUMENT, THE EVALUATOR CONFIRMED THE REPORTED PROBLEM AND FOUND DAMAGE TO THE JAW AND TUBE. A VISUAL EXAMINATION FOUND THE TIP DETACHED AT THE PIN PIVOT POINT AND THE OUTER TUBE BENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS FORCEPS IN A KNEE ARTHROSCOPY, THE TIP OF THIS INSTRUMENT BROKE IN THE JOINT. THE TIP WAS ABLE TO BE RETRIEVED WITHOUT INJURY OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUTT LOW PROFILE FORCEPS, STRAIGHT 3.4MM DIA FORCEPS, DISSECTING GEN CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK