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

Model Number	SYNERGY RESECTION SHAVER CONSOLE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex employee via email that for an ar-8305, (synergy resection shaver console) was returned from the qld office.It was unknown if the unit was working.The unit was not on system base.Service tested the unit and found the display was not working and a burning smell was coming from the unit.This was detected at an unspecified time on (b)(6) 2023 with no case involvement.
Event or Problem Description
On 4th march 2024, it was reported by an arthrex employee via email that for an ar-8305, (synergy resection shaver console) while servicing on a loaner equipment the service and repair technician noticed burnt smell.This was detected at an unspecified time on 4th march 2024 with no case involvement.
Additional Manufacturer Narrative
Corrected data: b5: summary adjusted to correct awareness date, g3: adjusted to correct awareness date.

• 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: 18888734
• Report Number: 1220246-2024-01434
• Device Sequence Number: 2997876
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: 00888867123854
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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 RESECTION SHAVER CONSOLE
• Device Catalogue Number: AR-8305
• Device Lot Number: 10370807
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown