MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CENTRIFUGE US (REFURBISHED)

Model Number	ANGEL CENTRIFUGE US (REFURBISHED)
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.The reported failure was recreated.One unpackaged abs-10060r serial/batch number (b)(6) was received for evaluation.A visual inspection revealed scratches, marks, and scuffs around the housing.The returned device was connected to a power source and tested under normal use conditions to reproduce the reported issue(s).It was noted that the screen remained white and displayed no commands, with no reaction even when the buttons were tested.The most likely cause of the reported failure is a hardware issue due to wear and tear, as the device was manufactured 8 years ago, in 2017.Refer to investigation photos and video.
Event or Problem Description
On 01/13/2025, a sales representative reported via (b)(4) that an abs-10060r angel centrifuges screen would not power on.This occurred during a case, and the case was not completed as the centrifuge wouldn't work.

• Brand Name: ANGEL CENTRIFUGE US (REFURBISHED)
• 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: 21314017
• Report Number: 1220246-2025-00209
• Device Sequence Number: 8151173
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: (01)00888867249585(10)15004604
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 02/05/2025

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 CENTRIFUGE US (REFURBISHED)
• Device Catalogue Number: ABS-10060R
• Device Lot Number: 15004604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown