BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATT MR8 STRAIGHT

    MDR report key: 20406369 · Received October 9, 2024

    Report

    Report Number
    1625507-2024-00957
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 11, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K183515
    Adverse Event
    Yes
    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:NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. 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: EVALUATION DETERMINED THAT DETACHED BEARING. THE LIKELY CAUSE OF FAILURE IS DAMAGE TO THE BEARING. IT WAS ALSO NOTED DETERIORATION OF THE STAMP. 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

    DETAILS OF CORRECTION: IMF CODE F1205 REMOVED. 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 DURING THE PROCEDURE, THE BEARING AND BALL COMPONENTS BROKE AND FELL INTO THE SURGICAL FIELD IT SEEMED THAT THE BROKEN PIECES WERE DROPPED TO THE PATIENT'S BODY. IT WAS ALSO REPORTED THAT REVISION SURGERY WILL BE CONDUCTED TO REMOVAL OF THE BROKEN PIECES. IT WAS REPORTED THAT THERE WAS NO INTERVENTION PERFORMED AS A RESULT OF THE EVENT AND THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

    Description of Event or Problem · 0

    ON FOLLOWUP IT WAS CONFIRMED THAT THERE WAS NO BROKEN PIECES IN THE PATIENT'S BODY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21322 ATT MR8 STRAIGHT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS MR8-AS10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other