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

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
-complaint allegation is not confirmed.-one unpackaged abs-10060 serial number (b)(6) was returned for investigation.-functional testing results: 60ml of bovine blood with acd-a was processed on the device with standard settings at seven percent hematocrit.The device reported outputs of 34 ml platelet-poor plasma (ppp), 21 ml rbc, and 3 ml prp.The prp volume within the syringe was recorded as 3 ml.Aliquots of the wb and prp were analyzed for cbcs with the heska hematology analyzer (table 1).Please note that the prp had expected cellular foldx concentrations.-the complaint describes that the system in question, sn (b)(6), that an abs-10060 angel prp centrifuge would not spin properly or wouldn't spin at all.This error could not be replicated.-visual evaluation noted no issues with the device.Manufacturing date: 16-apr-2021 -no problem found.-see attached testing investigation memo.-refer to investigation photos.-the complaint allegation is not confirmed.
Event or Problem Description
On 05/27/2025, a facility representative reported via (b)(4) that an abs-10060 angel prp centrifuge would not spin properly or wouldn't spin at all.A case was involved, with no adverse effects for the patient.

• 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: 22284871
• Report Number: 1220246-2025-02524
• Device Sequence Number: 21051769
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: (01)00888867083974(11)210416(10)13129837
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/18/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Distributor Facility Aware Date: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown