BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INST 960-717 ADJ DRILL STOP, 3.2MM

    MDR report key: 6491850 · Received April 13, 2017

    Report

    Report Number
    1723170-2017-01034
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 9, 2017
    Report Date
    June 16, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00673978090498
    PMA / PMN Number
    K954276
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF EVENT, ADVERSE EVENT UPDATED AS THE REPORTED ISSUE WAS FOUND TO BE AN ADVERSE EVENT DUE TO THE DRILL GOING DEEPER INTO PATIENT THAN INTENDED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. DEVICE LOT NUMBER IS UNAVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER, THEREFORE, UNAVAILABLE. ON (B)(6) 2017 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT HE INSPECTED ALL THREE SETS THAT INCLUDED INST ADJ DRILL STOP 3.2MM. ALL INSTRUMENTS WERE TESTED AND FOUND TO BE FUNCTIONING PROPERLY, NO ISSUES WERE IDENTIFIED. IT WAS DEEMED LIKELY THE DRILL STOP USED IN THIS EVENT WAS NOT PROPERLY LOCKED IN PLACE, ALLOWING THE DRILL TO GO DEEPER THAN DESIRED. THE SITE STERILE PROCESSING DEPARTMENT (SPD) HEAD AND TECHNICIANS WERE ALL RE-TRAINED ON THE USE OF THE 3.2MM INST ADJ DRILL STOPS AND DEMONSTRATED THEY UNDERSTOOD LOCKING/UNLOCKING OF THE DEVICE CORRECTLY. NO PARTS WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AS THERE ARE NO MALFUNCTIONS. THIS EVENT WAS DETERMINED TO BE USE ERROR. THE SITE CONFIRMED THE PATIENT IN THIS EVENT SUFFERED NO INJURY AND WAS RECOVERING "JUST FINE", AS EXPECTED. THERE ARE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT ON (B)(6) 2017, ALLEGING THAT ON (B)(6) 2017, WHILE IN A SPINE PROCEDURE, THE SITE'S UNIVERSAL DRILL GUIDE (UDG) DRILL STOP WAS NOT FUNCTIONING PROPERLY, AND THE DRILL WENT DEEPER THAN EXPECTED. NO FURTHER DETAILS REGARDING THIS ISSUE, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273253 INST 960-717 ADJ DRILL STOP, 3.2MM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 00673978090498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention