MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY ID; LAPAROSCOPE

Model Number	CCU, ARTHREX SYNERGY ID
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2024
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
It was reported that the console no longer outputs an image via dvi (black image with camera head pulled out).The console also does not send a signal to the tablet (tablet does not boot up and does not shut down when it runs out of power, despite correct configuration).Tablet still starts manually, screen input is correct, which indicates the console.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(motherboard) this evaluation determined that the reported event occurred due to a failing motherboard.

• Brand Name: CCU, ARTHREX SYNERGY ID
• Common Device Name: LAPAROSCOPE
• 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: 21035635
• Report Number: 1220246-2024-09109
• Device Sequence Number: 20747248
• Product Code: GCJ
• UDI-Device Identifier: 00888867351189
• UDI-Public: (01)00888867351189(11)240130(10)15195904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: CCU, ARTHREX SYNERGY ID
• Device Catalogue Number: AR-3200-0025
• Device Lot Number: 15195904
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown