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

Model Number	ANGEL CENTRIFUGE US (REFURBISHED)
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
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 10/29/2024 it was reported by a sales representative via (b)(4) that an abs-10060r angel centrifuge gave a constant error malfunction.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged abs-10060r serial number (b)(6) was returned for investigation.Functional testing: the complaint describes that the system in question, sn (b)(6), produced a constant error malfunction.Upon powering up, the unit gave a light sensor calibrator error.The unit was power cycled three times in an effort to clear the alarm with no success.It is unclear if the error is the same.Testing could not be completed.The most likely cause for the reported failure can be attributed to wear and tear.

• 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: 20653352
• Report Number: 1220246-2024-08505
• Device Sequence Number: 8218633
• Product Code: ORG
• UDI-Device Identifier: 00888867249585
• UDI-Public: (01)00888867249585(10)11843811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/23/2024

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: 11843811
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown