BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS ACROMIOBLASTER

    MDR report key: 25212188 · Received May 19, 2026

    Report

    Report Number
    3014023545-2026-00001
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 19, 2026
    Manufacturer
    RENOVO, INC.
    Product Code
    HRX
    PMA / PMN Number
    K172092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ABRADER WAS IN PERFECT, AS-NEW CONDITION. THE LUMEN OF THE INNER SHAFT WAS PLUGGED WITH PATIENT SOIL. THIS BLOCKAGE OF EITHER BONE OR CARTILAGE PREVENTED THE SUCTION OF SALINE FROM THE OPERATIVE SITE WHICH INTENTIONALLY COOLS THE DEVICE AND PREVENTS OVERHEATING AT THE TIP. WITHOUT THIS COOLING PROCESS IN PLACE, THE FRICTION OF USING THE DEVICE ON BONE OR CARTILAGE CAN CAUSE HEAT AT THE DISTAL TIP OF THE DEVICE. IT IS NOT KNOWN WHY THE DEVICE WAS PLACED ON THE PATIENT'S SKIN RATHER THAN SIMPLY REMOVED FROM THE OPERATIVE SITE AS NORMAL; FURTHER THE DEVICE WAS RETURNED FOR INVESTIGATION AND MANUFACTURER CONCLUDED THAT NO CORRECTIVE ACTION NEEDED. THE COMPLAINT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE, BUT RATHER DUE TO THE TECHNIQUE USED DURING SURGERY.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT THE ABRADER CAUSED A BURN TO THE PATIENT DURING THE PROCEDURE. THE BURN OCCURRED WHEN THE SURGEON WAS REMOVING THE BUR FROM THE SHOULDER. THE BURN IS 4 X 2 CM, AND IS ADJACENT TO THE PORT INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49079 DYONICS ACROMIOBLASTER ARTARTHROSCOPIC ABRADER HROSCOPIC ABRADER HRX RENOVO, INC. AB-72200730 L- 031648-50248

    Patients

    Seq Age Sex Outcome Treatment
    1