MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY RESECTION SHAVER CONSOLE; POWERED SURG ORTHOPEDIC INSTR

Model Number	SYNERGY RESECTION SHAVER CONSOLE
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
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)2024, it was reported by a distributor via sems-06532027 that an ar-8305 synergy console got water into one of the accessory ports on the front of the shaver console, and that port is no longer working.This was discovered during an unspecified procedure, with no patient harm reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 (device not returned) the most likely cause for the reported event is moisture intrusion, damage to hp/sf board.This was attributed to use error.

• Brand Name: SYNERGY RESECTION SHAVER CONSOLE
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 19202988
• Report Number: 1220246-2024-02557
• Device Sequence Number: 7926917
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: 00888867123854
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: SYNERGY RESECTION SHAVER CONSOLE
• Device Catalogue Number: AR-8305
• Device Lot Number: 10321107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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