BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATT ANGLED

    MDR report key: 20384123 · Received October 7, 2024

    Report

    Report Number
    1625507-2024-00949
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 16, 2024
    Report Date
    February 5, 2026
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00763000440220
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION OF THE DEVICE DETERMINED DETACHED BEARINGS. THE LIKELY CAUSE WAS IDENTIFIED AS A WORN SHAFT. IT WAS ALSO NOTED TWIST LOCK IS STUCK AND CAN'T BE TURNED INTO THE LOCKED POSITION; COLOR BAND WAS SCRATCHED. DATE OF EVENT NOTIFICATION: 2024-09-19. 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.

    Description of Event or Problem · 0

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF LOSS OF POWER. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2541846 ATT ANGLED MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS AA10 00763000440220

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown