BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT CARTILAGE CLAMP 8

    MDR report key: 1734730 · Received June 22, 2010

    Report

    Report Number
    2430952-2010-00028
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS, INC.
    Product Code
    GDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTS THAT THE JAW BROKE 1MM UP FROM THE HINGE. THERE WAS PATIENT CONTACT, NO PATIENT INJURY. ON (B)(6) 2010 THE CUSTOMER REPORTS VIA TELEPHONE THAT THE BREAK WAS BETWEEN THE DISTAL TIP AND THE BOX LOCK. THE TIP WAS RETRIEVED FROM THE FLOOR NOT THE PATIENT. TOTAL KNEE WAS BEING PERFORMED. NO PATIENT INJURY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT CARTILAGE CLAMP 8 NA GDJ J. JAMNER SURGICAL INSTRUMENTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1