BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 18767247 · Received February 23, 2024

    Report

    Report Number
    1625507-2024-00051
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 29, 2024
    Report Date
    July 8, 2024
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00763000172879
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE OF FDC D20 IS APPLICABLE FOR PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4). CODE OF FDR C070603 WAS NOT SUBMITTED IN EARLIER REPORT. 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: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT THE, UNABLE TO INSERT TOOL INTO THE ATTACHMENT, BEARINGS WERE BROKEN AND CORRODED. OUTPUT DRIVE SHAFT ASSEMBLY FOUND CORRODED. HENCE IT WAS UNABLE TO PERFORM PRE REPAIR TEMPERATURE TEST. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4). H2: CODES OF FDM B17, FDR C20, FDC D14 ARE APPLICABLE FOR PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6). ADDITIONAL CODE OF IMG G04063 IS APPLICABLE FOR PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6). H3: PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4). WAS NOT RETURNED AND SUPPLEMENTAL REPORT WILL BE SUBMIT TED IF ANY INFORMATION IS RECEIVED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO FAULT OBSERVED WITH HANDPIECE AND WAS WORKING FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT AND INDIGO HANDPIECE HAD HEATING ISSUE. WHICH WERE HEATING WITHIN A MINUTE WHEN RUNNING AT 50000 RPM, OPERATED IN FORWARD MODE USING MANUAL IRRIGATION. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112205 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS 1845020 216962678 00763000172879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown