BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ANGEL PRP KIT (US TRAY)

    MDR report key: 23465206 · Received November 4, 2025

    Report

    Report Number
    1220246-2025-04984
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 24, 2025
    Report Date
    March 20, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867279919
    PMA / PMN Number
    BK180180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE OF THE ANGEL PRP KIT, IS THE EXTERNAL POWER SOURCE WHERE THE MACHINE WAS PLUGGED IN. THE FAILURE MAY HAVE RESULTED FROM A DEFECTIVE OR COMPROMISED ELECTRICAL OUTLET RATHER THAN A DEVICE-RELATED MALFUNCTION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 10/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10061T ARTHREX ANGEL PRP KIT EXPERIENCED A MALFUNCTION. THE BLOOD WAS NOT PULLED UP DURING THE SPIN CYCLE AT ALL. THERE WAS ALSO A BURNING SMELL COMING FROM THE OUTLET WHERE THE MACHINE WAS PLUGGED IN. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739532 ARTHREX ANGEL PRP KIT (US TRAY) PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY) 4339155000 00888867279919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown