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

Model Number	SYNERGY RESECTION SHAVER CONSOLE
Medical Device Problem Codes	Moisture Damage (1405); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a facility representative reported via (b)(4) that an ar-8305 synergy resection shaver console got wet in a case, and it doesn't work.No patient was harmed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Device ar-8305, eaj200104 was subjected to functional testing per wi-000103653 using a known good test handpiece.All functional criteria were met.Each port was tested using an appropriate known good test device.No functional issues were observed.The voltages were checked on the handpiece and footswitch circuits using a multimeter and were found to be within normal values.An endoscope was used to visually inspect the hand switch board and the foot switch board.Moisture residue was found on the handpiece board at the connector component.The reported event of "an ar-8305 synergy resection shaver console got wet in a case, and it doesn't work" was confirmed and attributed to use error resulting in moisture intrusion.

• 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: 22742978
• Report Number: 1220246-2025-03332
• Device Sequence Number: 8419214
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: (01)00888867123854(11)201007(10)11767437
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 11767437
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown