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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
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 (b)(6) 2025, a sales representative reported via (b)(4) that an abs-10061t arthrex angel® prp kit malfunctioned and was damaged.This occurred during a case while attempting to spin blood for prp, the angle machine misjudged the amount of blood that had been transferred to the centrifuge, which resulted in an insufficient amount of blood being spun, resulting in a zero prp yield.We had to draw another 52 cc of blood from the patient, delaying the case in total about 30-40 minutes.The tubing also was punctured during the spinning, causing a small amount of leaking of blood.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper device surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 21884429
• Report Number: 1220246-2025-01651
• Device Sequence Number: 8146733
• Product Code: ORG
• UDI-Device Identifier: 00888867279919
• UDI-Public: (01)00888867279919(11)231101(17)261031(10)4354155397
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/02/2025

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: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Device Lot Number: 4354155397
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown