BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATT FOOTED

    MDR report key: 20190643 · Received September 11, 2024

    Report

    Report Number
    1625507-2024-00655
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00721902481864
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: EVALUATION DETERMINED THAT COMPRESSION NUT IS LOOSE. THE LIKELY CAUSE OF FAILURE IS INADEQUATE PREVENTIVE MAINTENANCE. IT WAS ALSO NOTED DISTAL BEARING IS DETACHED, COLOR RING IS DISCOLORED, LASER MARKINGS ARE FADED AND PARTIALLY ILLEGIBLE. DATE OF EVENT NOTIFICATION: 2024-07-26. 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

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF DETACHMENT OF COMPONENT. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562251 ATT FOOTED MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS AF03 00721902481864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown