BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER 9735023 SOLERA 5.5/6.0 MAS

    MDR report key: 9646819 · Received January 30, 2020

    Report

    Report Number
    1723170-2020-00291
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 19, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT INFORMATION PROVIDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    2020-JAN-31 PATIENT INFORMATION PROVIDED. LENGTH OF SURGICAL DELAY IS LESS THAN ONE HOUR.

    Additional Manufacturer Narrative · 1

    PENDING PATIENT INFORMATION. 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 THAT WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT (3) 5.5/6.0 DRIVER TIPS HAVE SHEARED OFF. THIS IS ALL THE INFORMATION THAT WAS PROVIDED AT THIS TIME. NO PATIENT PRESENT. 2020-JAN-17 IT WAS REPORTED THAT POWERCASE WAS USED TO PLACE THE SCREWS; THE ISSUE NEVER OCCUR WHEN PLACING THE SCREWS. IT ALWAYS HAPPEN WHEN THEY GO BACK IN WITH THE NAV DRIVER ON A T HANDLE AND TRY TO DRIVE THE SCREW IN A LITTLE FURTHER. IT WAS SUGGESTED THAT THE ISSUE COULD BE THAT THE DRIVER ISN¿T SEATED ENOUGH WHEN THE SURGEON PUTS TORQUE ON IT CAUSING THAT TIP TO SHEAR OFF. THE DRIVER WAS REQUESTED TO BE RETURNED. 2020-JAN-27 INITIAL REPORTER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109661 DRIVER 9735023 SOLERA 5.5/6.0 MAS INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735023 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR