MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY MATRIX MANAGEMENT SOFTWARE; MEDICAL DEVICE DATA SYSTEM

Model Number	SYNERGY MATRIX MANAGEMENT SOFTWARE
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/1/2023, it was reported by a sales representative via (b)(4) that an ar-3200-1036 synergy matrix management software had an issue.During a case in or 3, 2 boom monitors went black.Initially only one of the monitors went out and then came back, then another monitor went out, and came back, then both went out at the same time and didn't come back.The monitors were using sdi at the time because the tech never routed using the elo.The blackouts occurred while using the fail-over sdi mode.The case was completed with no patient harm as the sales representative routed using the elo.
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.
Additional Manufacturer Narrative
Additional information: (no problem found) the evaluation did not identify any issues relevant to the reported event.

• Brand Name: SYNERGY MATRIX MANAGEMENT SOFTWARE
• Common Device Name: MEDICAL DEVICE DATA SYSTEM
• 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: 18220867
• Report Number: 1220246-2023-08945
• Device Sequence Number: 6061623
• Product Code: OUG
• UDI-Device Identifier: 00888867253902
• UDI-Public: 00888867253902
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/24/2024

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: SYNERGY MATRIX MANAGEMENT SOFTWARE
• Device Catalogue Number: AR-3200-1036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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