BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 22075691 · Received May 23, 2025

    Report

    Report Number
    1045254-2025-01384
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 4, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00643169882621
    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

    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), UDI#:(B)(4). IMG CODE FOR PRODUCT ID: 1845020 IS: G04130 MANUFACTURING DATE: 2020-03-04 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: ANALYSIS FOUND THAT CUSTOMER COMPLAINT HAS NOT BEEN CONFIRMED. MOTOR AND COLLET BEARINGS ARE WORN AND CORRODED. PRE REPAIR TEMPERATURES AT T1 92 °F AND T2 94°F. H6: CODES ARE UPDATED. PREVIOUSLY UPDATED FDM B17, FDR C20 ARE NO MORE APPLICABLE. ANALYSIS FOR PRODUCT ID: 1845020: H3: ANALYSIS FOUND THAT THE REASON FOR RETURN HAS NOT BEEN CONFIRMED. BEARINGS, O RING ARE WORN. NOSE CONE DAMAGED. LASER MARKINGS ARE FADED. PRE REPAIR TEMPERATURES AT ANGLE 80 °F AND BASE 83°F AND BEARINGS: 90°F. H6: CODES ARE UPDATED. PREVIOUSLY UPDATED FDM B17, FDR C20 ARE NO MORE APPLICABLE. ANALYSIS FOR PRODUCT ID: 1845010: H3: ANALYSIS FOUND THAT CUSTOMER COMPLAINT HAS NOT BEEN CONFIRMED. BEARINGS ARE ROUGH AND WORN. PRE REPAIR TEMPERATURES AT ANGLE 79 °F AND BASE 80°F AND BEARINGS: 83°F. H6: CODES ARE UPDATED. PREVIOUSLY UPDATED FDM B17, FDR C20 ARE NO MORE APPLICABLE. PRODUCT ANALYSIS 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL WAS OVERHEATING WHEN IN USE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367344 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MEDTRONIC XOMED INC. 1845000 219306262 00643169882621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."