MAUDE Adverse Event Report: ARTHREX, INC. ANGEL PRP SYSTEM CENTRIFUGE US (NEW)

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Codes	Pressure Problem (3012); Pumping Problem (3016)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
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 01/21/2025, a facility representative reported via (b)(4) that an abs-10060 angel centrifuge was not pumping back.This occurred during a case.There was no additional information provided, and additional information has been requested.
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 settings.These factors may have contributed to the malfunction of the abs-10060 centrifuge, potentially affecting its performance during operation.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: ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
• Common Device Name: CENTRIFUGE
• 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: 21366311
• Report Number: 1220246-2025-00409
• Device Sequence Number: 8416551
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: (01)00888867083974(11)210416(10)13129837
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 PRP SYSTEM CENTRIFUGE US (NEW)
• Device Catalogue Number: ABS-10060
• Device Lot Number: 13129837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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