BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

    MDR report key: 5079757 · Received September 15, 2015

    Report

    Report Number
    1723170-2015-01099
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 17, 2015
    Report Date
    November 8, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    OLO
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURING DATES ARE 12/11/2014 FOR CLAMP W/LOT #141211 AND 03/04/2015 FOR CLAMP W/LOT #150304. (B)(4) 2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE SITE REQUESTED TWO REPLACEMENT SURETRAK2 MEDIUM CLAMPS AND RETURNED TWO DAMAGED CLAMPS TO THE MEDTRONIC REPRESENTATIVE FOR ANALYSIS. (B)(4) 2015 HARDWARE INVESTIGATION WAS COMPLETED. THIS ISSUE WAS FOUND RELATED TO A HARDWARE ISSUE AND WAS DOCUMENTED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE. RETURN REQUESTED. TWO REPLACEMENT SURETRAK2 MEDIUM CLAMPS SHIPPED TO SITE. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT SURETRAK2 MEDIUM CLAMPS FINDS THAT THE SET SCREWS HAVE NOT BEEN STRIPPED, BUT HAVE BEEN CROSS THREADED ON BOTH CLAMPS. NOT ABLE TO CLOSE EITHER CLAMP. SCREW CROSS-THREADED - MECHANICAL FAILURE.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE INDICATING THAT THE SET SCREW ON THEIR SURETRAK2 MEDIUM CLAMP WAS STRIPPED. ISSUE DISCOVERED WHILE SETTING-UP FOR A SURGERY THE PREVIOUS DAY. THE SITE WAS ABLE TO PROCEED WITH THE PROCEDURE USING THE OTHER CLAMPS IN THEIR SET. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO CLINICAL IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610147 SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 141211 & 150304

    Patients

    Seq Age Sex Outcome Treatment
    1