BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIFY HALO

    MDR report key: 24696600 · Received March 26, 2026

    Report

    Report Number
    3015392173-2016-00001
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 26, 2026
    Manufacturer
    SURGIFY MEDICAL OY
    Product Code
    HBE
    UDI-DI
    06429811532045
    PMA / PMN Number
    K251433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE HOSPITAL STAFF AND, THEREFORE, COULD NOT BE RETRIEVED AND INSPECTED. THE DHR OF THE LOT WAS REVIEWED. TWO DEVICES FROM THE SAME LOT WERE TESTED TO SIMULATE REPORTED CONDITIONS; THE FAILURE WAS NOT REPRODUCED. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT SURGIFY MEDICAL OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT. IF ANY FURTHER INFORMATION BECOMES KNOWN THAT COULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    DURING MINIMALLY INVASIVE BIPORTAL SURGERY, THE BURR BROKE/DISASSEMBLED AFTER LESS THAN 10 MINUTES OF USE (NOTE: THE LABEL INDICATES A USE TIME OF 5 MINUTES). THE DEVICE WAS USED AT 15K RPM (LABEL MAX 80K). CONTINUOUS IRRIGATION WAS USED DURING THE SURGERY. BASED ON THE INFORMATION RECEIVED, THE DEVICE PERFORMED AS EXPECTED PRIOR TO FAILURE, AND NO ABNORMALITIES WITH THE PROCEDURE WERE REPORTED. MANUFACTURE'S REPRESENTATIVES WERE NOT PRESENT DURING THE SURGERY. THE BREAKING OF THE BURR AND COLLECTING THE PIECES LED TO A DELAY OF THE SURGERY. NO HARM WAS CAUSED TO THE PATIENT. ALL PARTS WERE RECOVERED, AND AFTER PHOTOGRAPHING THEM, THE HOSPITAL STAFF DISCARDED THE PIECES, AND THUS THEY COULD NOT BE INVESTIGATED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760255 SURGIFY HALO DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE SURGIFY MEDICAL OY 40.125.NVG.H1 10229 06429811532045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown