BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATT MR8 ANGLED

    MDR report key: 18994669 · Received March 28, 2024

    Report

    Report Number
    1625507-2024-00098
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 6, 2025
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    UDI-DI
    00643169912717
    PMA / PMN Number
    K183515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 PRODUCT ANALYSIS: EVALUATION COULD NOT BE POSSIBLE AS THE DEVICES WERE SCRAPPED. 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

    CORRECTION DONE IN D TAB: CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: MR8-AA07, SERIAL/LOT #: (B)(6), UDI#: (B)(4); PRODUCT ID: MR8-AS09, SERIAL/LOT #: (B)(6), UDI#: (B)(4) ; PRODUCT ID: MR8-AF02, SERIAL/LOT #: (B)(6), UBD: 25-MAY-2028, UDI#: (B)(4) ; PRODUCT ID: MR8-AS07, SERIAL/LOT #: (B)(6), UBD: 25-MAY-2028, UDI#: (B)(4). ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICES (: PRODUCT ID: EM800, SERIAL/LOT #: (B)(6), UDI#: (B)(4); PRODUCT ID: MR8-7TA11, SERIAL/LOT #: (B)(6), UBD: 26-JAN-2028, UDI#: (B)(4) ; PRODUCT ID: MR8-7BA40D, SERIAL/LOT #: (B)(6), UBD: 05-SEP-2028, UDI#: (B)(4) ; PRODUCT ID: MR8-9BA30, SERIAL/LOT #: (B)(6), UBD: 04-AUG-2027, UDI#: (B)(4) ; PRODUCT ID: MR8-F2/7TA23, SERIAL/LOT #: (B)(6), UBD: 25-MAY-2028, UDI#: (B)(4) IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.¿ 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

    CORRECTED THE INFORMATION OF SECTION G ALL MANUFACTURERS. H3: DEVICE EVALUATION OF DEVICE MR8-AS09 (P30619447) AND MR8-AS07 (P30719984): EVALUATION DETERMINED THAT INTERNAL TUBE BEARINGS ARE CORRODED. THE LIKELY CAUSE OF FAILURE COULDN'T ABLE TO DETERMINE. 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

    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. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: MR8-AD03, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4); PRODUCT ID: MR8-AA07, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4); PRODUCT ID: MR8-AS09, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4); PRODUCT ID: MR8-7TA11, SERIAL/LOT #: (B)(6), UBD: 26-JAN-2028, UDI#: (B)(4); PRODUCT ID: MR8-7BA40D, SERIAL/LOT #: (B)(6), UBD: 05-SEP-2028, UDI#: (B)(4); PRODUCT ID: MR8-9BA30, SERIAL/LOT #: (B)(6), UBD: 04-AUG-2027, UDI#: (B)(4); PRODUCT ID: MR8-F2/7TA23, SERIAL/LOT #: (B)(6), UBD: 25-MAY-2028, UDI#: (B)(4); PRODUCT ID: MR8-AF02, SERIAL/LOT #: (B)(6), UBD: 25-MAY-2028, UDI#: (B)(4); PRODUCT ID: MR8-AS07, SERIAL/LOT #: (B)(6), UBD: 25-MAY-2028, UDI#: (B)(4). 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 PATIENT WAS OPERATED FOR RESECTION OF MENINGIOMA OF OLFACTORY TRACT (TUMOR REMOVAL) PROCEDURE. POST OPERATION, A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND THE RAYS WERE FOUND SCATTERING DUE TO A FOREIGN BODY (SPHERE METAL BALL) OF 1 MILLI METER IN SUBDURAL LOCATION. IT WAS REPORTED THAT THE METAL BALL GOT RELEASED FROM THE DRILL IN THE OPERATION PROCEDURE. THE HEALTH CARE PROFESSIONAL PERFORMED A SECOND SURGERY TO RETRIEVE THE BALL. AS PART OF SECOND SURGERY, THE PREVIOUS RIGHT FRONTO-PTERIONA WOUND WAS REOPENED AND A SMALL PART OF DURAL WAS OPENED. THE SPHERE METAL BALL WAS LYING BELOW CEREBRAL PERCHYMA WHICH WAS THEN REMOVED. IT WAS REPORTED THAT THERE WAS A DELAY IN SURGERY FOR 120 MINUTES AND THE PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT. IT WAS ALSO REPORTED THAT ALL THE ATTACHMENTS WERE FINE WITHOUT SIGNALS OF RUPTURES OR BREAKAGES AND THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370235 ATT MR8 ANGLED MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS MR8-AD03 00643169912717
    501115 ATT MR8 ANGLED MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS MR8-AD03 00643169912717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention