BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROLOGICAL STEREOTAXIC INSTRUMENT

    MDR report key: 19721314 · Received July 11, 2024

    Report

    Report Number
    3012165443-2024-00019
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 6, 2024
    Report Date
    August 7, 2024
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9, H2, H3: THE HARDWARE WAS RETURNED AND ANALYSIS WAS PERFORMED. ONLY THE SINGLE SCREW WAS RETURNED. AS REPORTED, THE SCREW HAD BEEN BROKEN. CODES B01, C07, D02 ARE APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CODES: B17, C20, D15 G2) FOREIGN COUNTRY: JAPAN MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE EVENT OCCURRED INTRA-OPERATIVELY.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THE SCREW GOT DAMAGED DURING THE PROCESS OF FIXATING THE BASE OF THE TRAJECTORY GUIDE WITH THE SCREW. THERE WAS INQUIRY ABOUT THE CAUSE OF DAMAGE AND THE MATERIAL OF THE SCREW. IN THE PROCESS OF FIXATING THE SCREW WITH A SCREWDRIVER, IT GOT DAMAGED. PART OF THE DAMAGE WAS LEFT IN THE BONE, SO REMOVAL WAS PERFORMED. THE TIMING OF SCREW BREAKAGE IS NOT AT THE TIME OF FIXATION BUT AT THE TIME OF EXTRACTION. CONFLICTING INFORMATION WAS RECEIVED WHETHER A PATIENT WAS OR WASN'T PRESENT AT THE TIME OF EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS A PATIENT PRESENT. THE INSTRUMENT WAS BROKEN INSIDE THE PATIENT'S SKULL. NO PART WAS LEFT IN THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT'S OUTCOME AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. THE PROCEDURE BEING PERFORMED WAS A BRAIN TUMOR BIOPSY AND THERE WAS A 5-10 MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272788 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW QUALITY TECH SERVICES LLC 9733066 066211122A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown