MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGYUHD4, MATRIX; LAPAROSCOPE

Model Number	CCU, ARTHREX SYNERGYUHD4, MATRIX
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3200-0020 ccu was having connectivity issues; it would disconnect while in use and would only connect upon restarting.Also, the camera head buttons are losing functionality and have become unresponsive in the middle of a case, and then would have to have the images taken from the tablet.This was discovered during an unspecified procedure, with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.(device not returned) the most likely cause for the reported event is a failing motherboard.

• Brand Name: CCU, ARTHREX SYNERGYUHD4, MATRIX
• 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: emily shafer ; 8009337001
• MDR Report Key: 17724562
• Report Number: 1220246-2023-07854
• Device Sequence Number: 20623715
• Product Code: GCJ
• UDI-Device Identifier: 00888867216549
• UDI-Public: 00888867216549
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• 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): 12/05/2024

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: CCU, ARTHREX SYNERGYUHD4, MATRIX
• Device Catalogue Number: AR-3200-0020
• Device Lot Number: 10262262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2018
• 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