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	12/19/2024
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 12/19/2024, a sales representative reported via sems-06739359 that an abs-10060 angel prp system centrifuge us (new) was displaying many error codes when in use and continued to pause during mid-spin.They tried wiping down the laser and eyepiece, but the issue persisted.They had to keep pressing to make the device work.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
Additional information was received on 01/16/2025: this was discovered during a bmac for a foot fusion procedure with anesthesia on (b)(6) 2025.The case was completed using the same angle complaint device.There was no case delay reported and no adverse effects on the patient.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.One unpackaged, abs-10060r, angel prp system centrifuge us, 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), displayed a multitude of error codes.This error could not be replicated.No problem found.

• 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: 21157704
• Report Number: 1220246-2025-09464
• Device Sequence Number: 7631043
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: (01)00888867083974(11)180607(10)10216425
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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: 10216425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided; 02/19/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/29/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown