BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAJECTORY GUIDE BIOPSY

    MDR report key: 11686033 · Received April 19, 2021

    Report

    Report Number
    3012165443-2021-00003
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 19, 2021
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE SITE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE SCREWS ON THE BASE IN THE TRAJECTORY GUIDE KIT WERE NOT ENTERING IN THE SKULL WELL. THEY WERE SUPPOSED TO BE SELF-TAPPING AND THE HEALTH CARE PROFESSIONAL WAS HAVING ISSUES INSERTING THEM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED STATING THAT THE HEALTH CARE PROFESSIONAL FOUND THAT THE INSTRUMENT WAS DAMAGED AT THE BEGINNING OF THE PROCEDURE. THE PROBABLE CAUSE OF THE REPORTED ISSUE IS THAT THERE SEEMS TO BE A PROBLEM WITH THE SCREWS AS THEY USUALLY ARE EASY TO INSERT AND THEY ARE EXPERIENCING PROBLEM LATELY WITH THE SCREWS. THE SITE STATED THAT THE SCREWS DON'T SEEM TO BE SELF-TAPPED AS USUAL. THE REPORTED ISSUE OCCURRED DURING A CRANIAL BIOPSY. THERE WAS NO ADVERSE EVENT WITH THE PATIENT AND THERE WAS ABOUT A 5 MINUTE DELAY TO THE CASE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE HEALTH CARE PROFESSIONAL OPENED A NEW KIT AND WAS ABLE TO CONTINUE WITH THE CASE. NAVIGATION WAS NOT ABORTED AND THERE WAS NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584552 TRAJECTORY GUIDE BIOPSY INSTRUMENT, STEREOTAXIC HAW QUALITY TECH SERVICES LLC 9733066 066231720

    Patients

    Seq Age Sex Outcome Treatment
    1