BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT BONE HOOK 9 MED 3/4

    MDR report key: 1702189 · Received May 18, 2010

    Report

    Report Number
    2430952-2010-00019
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Report Date
    May 18, 2010
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEALER REPORTS FOR THE CUSTOMER THAT AFTER USING THE DEVICE ONE TIME, THE TIP BENT. THERE WAS NO PT INJURY. ON (B)(6) 2009, CUSTOMER ADDS THAT THE DEVICE WAS BEING USED DURING A TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT BONE HOOK 9 MED 3/4 N/A GDG J. JAMNER SURGICAL INSTRUMENTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1