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

Model Number	SYNERGY RESECTION SHAVER CONSOLE
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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
On 01/24/2025, it was reported by a sales representative via (b)(4) that an ar-8305 shaver console is "acting up".It will intermittently cut in and out.There was possible spill damage to the machine.There was also a small delay to the case.The procedure that should've taken 20 minutes took 30.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(use error) this evaluation determined that the reported event occurred due to use error resulting in moisture damage to the foot switch board.

• 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: 21374970
• Report Number: 1220246-2025-00434
• Device Sequence Number: 3849355
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: (01)00888867123854(11)240722(10)NB
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• 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): 03/07/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown