BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST 960-339 EGG QUICK CONNECT HANDLE

    MDR report key: 5947677 · Received September 13, 2016

    Report

    Report Number
    1723170-2016-02274
    Event Type
    Malfunction
    Date Received
    September 13, 2016
    Date of Event
    August 16, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING DATE PROVIDED. ONE OF THE THREE HANDLES (LOT NUMBER 130422) ALLEGED TO HAVE BROKEN WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE IMPACT CAP WAS NOT BROKEN AS REPORTED. THE RETURNED HANDLE IS WELL WORN WITH MANY NICKS ON THE IMPACT CAP. THE HANDLE RECEIVES AND RELEASES INSTRUMENTS WITHOUT ISSUE. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURING DATES ARE NOT AVAILABLE. RETURN REQUESTED FOR 3 RATCHETING HANDLES. 3 REPLACEMENT RATCHETING HANDLES SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THEIR 3 NAVIGATION INSTRUMENTS WERE DAMAGED. THEY HAVE 3 BROKEN RATCHETING HANDLES, IMPACTOR BROKEN ON EACH. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. REPLACEMENT DEVICES WERE REQUESTED. THE SITE REPRESENTATIVE STATED THAT THESE DEVICE ISSUES ARE BEING REPORTED AS NO PATIENT PRESENT AND THERE WAS NO IMPACT ON THE PATIENTS NOR ON THE SURGERIES. THE SITE DEPARTMENT HEAD IS NOT ABLE TO LINK THESE ISSUE TO SPECIFIC SURGERIES ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598518 INST 960-339 EGG QUICK CONNECT HANDLE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 130422, 65638, 65330

    Patients

    Seq Age Sex Outcome Treatment
    1