MAUDE Adverse Event Report: ARTHREX, INC. ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA; PLATELET AND PLASMA SEPARATOR

Model Number	ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/05/2025, it was reported by a sales representative via (b)(4) that an abs-10062t angel system with aspiration kit separation chamber in the processing kit did not lock into the centrifuge.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
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 for the reported failure can be attributed to misuse due to improper surgical technique.According to dfu-0260-r0, "loading the variable-volume separate chamber should always be the first step in the setup process.Loading the variable-volume separation chamber and pressing down on the separation chamber plate will remove the excess air volume from the chamber.If the excess air is not removed, the separation chamber plate will not load properly.".

• Brand Name: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22095747
• Report Number: 1220246-2025-02243
• Device Sequence Number: 20799917
• Product Code: ORG
• UDI-Device Identifier: 00888867239951
• UDI-Public: (01)00888867239951(11)240701(17)270630(10)4354155400
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• Device Catalogue Number: ABS-10062T
• Device Lot Number: 4354155400
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown