BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 20784840 · Received November 26, 2024

    Report

    Report Number
    1045254-2024-02055
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    September 30, 2024
    Report Date
    December 27, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF THE DEVICE CONCLUDED THAT THE MOTOR WAS LITTLE NOISY. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1845020, SERIAL/LOT #: (B)(6) , UDI#: (B)(4), H3: PRODUCT ANALYSIS OF PRODUCT ID: 1845020, SERIAL/LOT #: (B)(6), CONCLUDED THAT THE INTERNAL PARTS WERE CORRODED AND COULD NOT GRIP THE BUR. H6: CODE OF FDR C0601 AND ADDITIONAL CODE OF G04130 IS APPLICABLE FOR PRODUCT ID: 1845020, SERIAL/LOT #: (B)(6). 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H6: CODE OF D02 IS APPLICABLE PRODUCT ID: 1845020, SERIAL/LOT #: (B)(6)/207221953. AND D20 IS APPLICABLE FOR BOTH THE DEVICES. 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

    IT WAS REPORTED THAT INTRA-OP, THE TIP OF THE BUR WAS WOBBLING WHEN HANDPIECE IN USE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT ANOTHER BUR WAS TESTED WITH HANDPIECE AND ATTACHMENT AND IT WORKED WELL WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411957 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MEDTRONIC XOMED INC. 1845000 207260166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".