BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM II SUTURE HOOK MED CRESCENT LTD REUSE

    MDR report key: 1664484 · Received April 14, 2010

    Report

    Report Number
    1017294-2010-00053
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 5, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT UPON RECEIPT OF THIS SUTURE HOOK AND COMPLETION OF AN INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING FIRST TIME USE OF THIS SUTURE HOOK, THE TIP DETACHED IN THE SURGICAL SITE. THE USER RETRIEVED THE TIP AND COMPLETED THE PROCEDURE AS INTENDED BY USING AN ALTERNATE SUTURE HOOK. THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM II SUTURE HOOK MED CRESCENT LTD REUSE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT GDG CONMED LINVATEC 129262

    Patients

    Seq Age Sex Outcome Treatment
    1