BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 21292378 · Received February 3, 2025

    Report

    Report Number
    1045254-2025-00240
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 8, 2025
    Report Date
    July 4, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 :IT WAS FOUND IN THE ANALYSIS THAT THE BEARING WAS CORRODED AND THE OUTPUT SHAFT WAS PINCHED. BASED ON THE PRE-REPAIR TEMPERATURE READING OF THE HANDPIECE AFTER 1 MINUTE WAS 80 F AT ANGLE, 79 F AT THE BASE, AND 81 F AT THE DISTAL BEARING. BASED ON THE TEMPERATURE READING, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA FOR REGULATORY REPORTING. THE TEMPERATURE RECORDED WAS BELOW 118F, WHICH IS WITHIN THE ACCEPTABLE RANGE AND THEREFORE NOT REPORTABLE. ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE 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 CRITERION. H6: FDM B17 AND FDR C20, IMG G04063, AND D16 CODES NO LONGER APPLICABLE. 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1 845020, SERIAL/LOT #: (B)(6), UBD: , 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS EVENT ON THE PROVIDED INFORMATION THAT THE INDIGO HANDPIECE WAS OVERHEATING WITHIN 2 MINUTES. THIS EVENT IS MEETING THE REPORTABLE CRITERION. CORRECTION - H6: FDM B01, FDR C0601 AND C070601, IMG G04011 AND G04112, AND FDC D02 CODES NO LONGER APPLICABLE. H6: FDM B17 AND FDR C20, IMG G04063, AND D1102 CODES ARE APPLICABLE. 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 PRIOR TO PROCEDURE INDIGO DRILL AND ATTACHMENT SCRUB NURSE STRUGGLED TO GET THE BURR TO GRIP. EVENTUALLY IT LOCKED, BUT SOON AFTER STARTING TO TEST IT, THE HANDPIECE OVERHEATED. IT WAS FURTHER STATED THE HANDPIECE GOT TOO HOT TO HOLD UNDER TWO MINUTES. THE DEVICE RUN AT 52000 RPM AND RUNNING ON STANDARD MODE. THE FLOW RATE WAS SET AT 30 CC/MIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190502 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MEDTRONIC XOMED INC. 1845000 214808634 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown