MAUDE Adverse Event Report: ARTHREX, INC. ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA; PLATELET AND PLASMA SEPARATOR

Model Number	ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/09/2023, it was reported by a sales representative via (b)(4) that an abs-10062t prp system with aspiration kit was filling up the prp syringe with air up to 17cc¿s while no blood was leaving the disc.This occurred during use, with no effect on the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation was not confirmed.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 a most likely cause.The reported failure is most likely due to a user error, following the correct surgical technique for the device.

• Brand Name: ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
• 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: emily shafer ; 8009337001
• MDR Report Key: 18314331
• Report Number: 1220246-2023-09344
• Device Sequence Number: 6267265
• Product Code: ORG
• UDI-Device Identifier: 00888867239951
• UDI-Public: 00888867239951
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/09/2025

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 SYSTEM WITH ASPIRATION KIT W/ ACDA
• Device Catalogue Number: ABS-10062T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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