BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 25217083 · Received May 19, 2026

    Report

    Report Number
    1625507-2026-01141
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00613994933706
    PMA / PMN Number
    K081475
    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 CONFIRMED REPORTED ISSUE OF WOBBLING. THE DISTAL BEARINGS WERE FOUND BROKEN AND THE LASER MARKINGS GOT FADED. 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). H3: DEVICE ANALYSIS OF PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6) DID NOT IDENTIFY ANY FAULT. H6: CODES OF IMDRF ANNEX C: C19, ANNEX D: D14 AND ANNEX G: G04063 ARE APPLICABLE FOR PRODUCT ID: 1845000, SERIAL/LOT #: (B)(6). 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 STRAIGHT HANDPIECE HAD A WORN BEARING, CAUSING THE BURR TO WOBBLE DURING USE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293723 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS 1845010 00613994933706

    Patients

    Seq Age Sex Outcome Treatment
    1