BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL CPRP PROCESSING SET USM

    MDR report key: 18362817 · Received December 20, 2023

    Report

    Report Number
    1220246-2023-09502
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 21, 2023
    Report Date
    January 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867084001
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 COMPLAINT ALLEGATION WAS NOT CONFIRMED. 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 REPORTED FAILURE IS MOST LIKELY DUE TO A USER ERROR, FOLLOWING THE CORRECT SURGICAL TECHNIQUE FOR THE DEVICE.

    Description of Event or Problem · 0

    ON 11/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10063 PRP PROCESSING SET WOULD NOT ALLOW THE CENTRIFUGE TO DEPOSIT THE PRP INTO THE SYRINGE. THIS OCCURRED DURING USE, WITH NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110424 ANGEL CPRP PROCESSING SET USM PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ANGEL CPRP PROCESSING SET USM 2022070128 00888867084001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown