BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

    MDR report key: 4294861 · Received December 3, 2014

    Report

    Report Number
    1723170-2014-01302
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 8, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RETURN REQUESTED. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT SURETRAK2 MEDIUM CLAMP FINDS THROUGH VISUAL INSPECTION THAT THE HEX HEAD ADJUSTMENT SCREW IS ROUNDED. WITH A 2.5MM ALLEN WRENCH INSERTED IN TO THE HEAD OF THE SCREW, THERE IS PLAY, IT DOES NOT FIT TIGHT. ALSO, WAS ABLE TO TIGHTEN THE CLAMP TO AN INSTRUMENT AND IT WAS SECURE. PHYSICAL DAMAGE TO THE HEAD. ROUNDED HEAD / DAMAGED SCREW.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INSTRUMENTS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND FOUND TO BE RELATED TO THE REPORTED EVENT: DEVICE #2: P/N: 961-579, L/N: 120217, BRAND NAME: FIGHTER SURETRAK II UNIVERSAL TRACKER, MEDIUM PASSIVE. PROCODE: HAW, 510K: K983670, MFR DATE: 02/17/2012. VISUAL INSPECTION FOUND THAT THE HEX HEAD ADJUSTMENT SCREW IS ROUNDED, ALSO THERE ARE TOOL MARKS ON THE HEAD OF THE SCREW. WITH A 2.5MM ALLEN WRENCH INSERTED IN TO THE HEAD OF THE SCREW, THERE IS PLAY, IT DOES NOT FIT TIGHT BUT WAS ABLE TO TIGHTEN THE FIGHTER TO THE CLAMP AND IT WAS SECURE. PHYSICAL DAMAGE TO THE HEAD. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. DEVICE #3: P/N: 961-580, L/N: 140430, BRAND NAME: SURETRAK II UNIVERSAL TRACKER, LARGE CLAMP. PROCODE: HAW, 510K: K983670, MFR DATE: 04/30/2014. VISUAL INSPECTION FOUND THAT THE HEX HEAD ADJUSTMENT SCREW IS ROUNDED. WITH A 2.5MM ALLEN WRENCH INSERTED IN TO THE HEAD OF THE SCREW, THERE IS PLAY, IT DOES NOT FIT TIGHT. ALSO WAS ABLE TO TIGHTEN THE CLAMP TO AN INSTRUMENT AND IT WAS SECURE. PHYSICAL DAMAGE TO THE HEAD. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

    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 SITE PURCHASING REPRESENTATIVE REPORTED A SURETRAK MEDIUM CLAMP THAT WAS DAMAGED AND REQUESTED REPLACEMENT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779777 SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 121217

    Patients

    Seq Age Sex Outcome Treatment
    1