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

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
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 12/13/2024, it was reported by a sales representative via (b)(4) that an abs-10060 angel prp system centrifuge us (new) pump motor keeps popping out when the angel is filling and un-filling.The perfusionist had to put his finger on it so it would not keep popping up.This was discovered during a procedure with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The complaint allegation was not confirmed.One unpackaged, abs-10060, angel prp system centrifuge, serial/batch number (b)(6), was received for evaluation.Visual inspection revealed no issues with the device.Functional testing was performed with 60ml of bovine blood with acd-a was processed on the device with standard settings at seven percent hematocrit.The complaint describes that the system in question, sn (b)(6), had mechanical failures with the black rotary pump.According to the complaint, the black rotary pump repeatedly popped up during the run.This error could not be replicated.The device reported outputs of 38ml platelet-poor plasma (ppp), 19ml rbc, and 4ml prp.The prp volume within the syringe was recorded as 3.6ml.Aliquots of the wb and prp were analyzed for cbcs with the heska hematology analyzer (see table 1 in memo).Please note that the prp had expected cellular foldx concentrations.Average concentrations and foldx of cbc data of wb and prp samples.No problem found.
Event or Problem Description
Additional information was received on 12/19/2024: this was during a triple arthrodesis of the foot procedure with anesthesia on (b)(6) 2024.The case was completed by holding down the black rotator on the angel, and the prp was then able to be expelled from the machine.There was no case delay and no adverse effects on 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: 21122828
• Report Number: 1220246-2025-09333
• Device Sequence Number: 21012302
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: (01)00888867083974(11)230801(10)152281
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 152281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown