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

Model Number	ANGEL PRP SYSTEM CENTRIFUGE US (NEW)
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/13/2024
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 09/13/2024, it was reported by a sales representative via sems-(b)(4) that an abs-10060 angel centrifuge was not out putting the proper amounts of prp.The issue occurred with a few different kits with the same outcome of 20cc+ of prp.
Additional Manufacturer Narrative
The complaint allegation of incorrect output is not confirmed due to the reported failure not being able to be replicated.One unpackaged abs-10060 serial number: (b)(6) was received for investigation.Visual evaluation of the returned device noted damage to the right corner of the returned device behind the pump motor.Functional testing results: damage was visible to the right corner of the unit behind the pump rotor, where the light sensor is housed.A light sensor calibration error was presented upon start up of the unit.A total of three power cycles were ran in an attempt to clear the error, with no success.Testing could not be completed.The most likely cause for the sensor calibration alarm can be attributed to misuse/mishandling due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• 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: 20277916
• Report Number: 1220246-2024-07795
• Device Sequence Number: 7934256
• Product Code: ORG
• UDI-Device Identifier: 00888867083974
• UDI-Public: (01)00888867083974(11)210602(10)13441355
• 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 PRP SYSTEM CENTRIFUGE US (NEW)
• Device Catalogue Number: ABS-10060
• Device Lot Number: 13441355
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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