BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATT MR8 FOOTED

    MDR report key: 19151898 · Received April 22, 2024

    Report

    Report Number
    1625507-2024-00128
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 25, 2024
    Report Date
    November 1, 2024
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00643169912403
    PMA / PMN Number
    K183515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: EVALUATION DETERMINED THAT DETACHED BEARING DISTAL. THE LIKELY CAUSE OF FAILURE IS INADEQUATE PREVENTIVE MAINTENANCE. IT WAS ALSO NOTED LEG SCRATCHED, RETAINING RING BWAS INPLACE OF A CLIP, AND TUBE INTERNAL TAMPERING. 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

    G2: REPORT SOURCE FIELD CORRECTED, IN INITIAL REPORT IT WAS SELECTED FOREIGN BUT THIS COMPLAINT IS FROM US SO IT IS NOT FOREIGN. 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: IME CODE E2119 REMOVED. IMF CODE F2203 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.

    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.

    Description of Event or Problem · 0

    ON FURTHER FOLLOW UP IT WAS REPORTED THAT THE BALL BEARING IS STILL IN PATHOLOGY AND WILL NOT BE GETTING THAT THEY WILL NOT RELEASE IT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALL BEARING WAS IN THE PATIENT BRAIN UNTIL A POST SCAN WAS PREFORMED, AS THE ATTACHMENT PROBABLY HAD WORN BEARING WHICH CAUSED ONE TO FALL OUT. IT WAS ALSO REPORTED THAT THERE WAS INTERVENTION PERFORMED IN WHICH THE PATIENT WAS BROUGHT BACK TO REMOVE THE BALL BEARING, THERE WAS NO PROCEDURE DELAY, THE BROKEN PIECE(S) WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). ON FOLLOW-UP IT WAS CONFIRMED THAT THE STATUS OF THE PATIENT AFTER THE OPERATION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587350 ATT MR8 FOOTED MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS MR8-AF02 00643169912403

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other