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

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/26/2025
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 26-dec-2025, a sales representative reported via (b)(4) that an abs-10060 angel centrifuge did not recognize that the lid was closed and would not allow the ¿green button¿ to be selected to start the process.This occurred during an arthroscopic hip scope and bma injection.After the patient¿s blood was loaded and the centrifuge was prepared for use, the lid was closed as usual; however, the system failed to detect the closed lid and prevented initiation.A different centrifuge was brought in to complete the procedure after a significant delay.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.10 minute ir led value failed with a value of 26266.When unit powered on, basic functions were checked and displayed error code.Additional functions will be verified at test.Error code-lid open (magnet on lid is missing).The ax020392-lf assembly does not contain a d3 component at risk for drifting, therefore drift test is not required and was not performed.See vendor evaluation.
Event or Problem Description
Additional information was provided on 29-dec-2025 where the sales representative stated that reported via (b)(4) that an abs-10061t was used with the centrifuge.The case was delayed 30-minutes and no additional anesthesia was administered.

• 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24039707
• Report Number: 1220246-2026-00165
• Device Sequence Number: 10504996
• Product Code: ORG
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: BK110046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 13548093
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown