BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT

    MDR report key: 8568458 · Received May 1, 2019

    Report

    Report Number
    1220246-2019-01068
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    November 7, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867239951
    PMA / PMN Number
    K180180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP SUBMISSION TO RESPOND TO AN FDA LETTER DATED 10/31/19 FROM (B)(6). THE LETTER STATED THAT THE ORIGINAL SUBMISSION (ARTHREX CASE (B)(4)) CITES K121124 WHICH IS FOR THE ARTHREX MIXING AND DELIVERY SYSTEM AND NOT FOR AN ABS-10062T, ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT. THE LETTER FURTHER STATES THAT A SUPPLEMENTAL REPORT WILL NEED TO BE SUBMITTED ELECTRONICALLY TO MAKE THE CORRECTION. THE CORRECT 510(K) SHOULD BE K180180 AND IS SHOWN IN SECTION G OF THIS SUPPLEMENTAL REPORT. AFTER THIS ELECTRONIC SUPPLEMENTAL SUBMISSION, CORRESPONDENCE BY E-MAIL WAS SENT TO MS. (B)(6) ALERTING HER OF THE ACTION TAKEN.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THE SURGEON ASPIRATED MARROW AND PASSED OFF THE FIELD FOR PROCESSING. WHEN THE BMC WAS SEPARATING INTO THE SYRINGE IT CONTINUED TO PUSH PRODUCT INTO THE SYRINGE UNTIL THE PLUNGER PUSHED OFF, LOSING ALL OF THE PRODUCT ONTO THE FLOOR. THE CASE WAS COMPLETED WITHOUT USING THE BMC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361996 ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING ORG ARTHREX, INC. ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA 831788025 00888867239951

    Patients

    Seq Age Sex Outcome Treatment
    1 Other