MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY); PLATELET AND PLASMA SEPARATOR

Model Number	ARTHREX ANGEL PRP KIT (US TRAY)
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
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 11/27/2024, it was reported by a sales representative via sems-06722915 that an abs-10061t angel disc plastic is too thick and unable to load in angel machine.This occurred during use in a case with no patient effect.It did not harm the patient as they had another angel kit and were able to put the blood in the one that worked.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is not confirmed.One unpackaged abs-10061t batch 4233152025 was received for evaluation.Visual inspection noted no issues with the exterior of the device.Functional testing was conducted with an angel.After removing the air from the variable volume separation chamber, the device was successfully placed in the centrifuge without any issues.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: ARTHREX ANGEL PRP KIT (US TRAY)
• 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: 21020183
• Report Number: 1220246-2024-09061
• Device Sequence Number: 3969238
• Product Code: ORG
• UDI-Device Identifier: 00888867279919
• UDI-Public: (01)00888867279919(11)230901(17)260831(10)4233152025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Expiration Date: 08/31/2026
• Device Model Number: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Device Lot Number: 4233152025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown