MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY RESECTION WIRELESS FS KIT; POWERED SURG ORTHOPEDIC INSTR

Model Number	SYNERGY RESECTION WIRELESS FS KIT
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-8315w synergy resection wireless fs kit smells like there is smoke coming from it.It is also not connecting to the bluetooth/wireless.No case/patient involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation that the ar-8315w synergy resection wireless footswitch would not connect is confirmed.The complaint allegation of a smoke smell is not confirmed.One unpackaged ar-8315w synergy resection wireless footswitch serial number:(b)(6) was received for investigation.Visual evaluation of the returned device noted wear and tear to the device with discolored metal observed around the pushbuttons.Functional testing was performed with a known good ar-8305 shaver console and it was found that when plugged into the console, the returned ar-8315w synergy resection wireless footswitch receiver red battery/status led indicator was flashing slowly, indicating it was not paired.Two new aa alkaline batteries were installed into the footswitch and pairing was attempted.Three attempts were made to pair the ar-8315w synergy resection wireless footswitch with the ar-8305 shaver console with no success.During functional testing, no smells were observed to come from the device.A smoke smell was not able to be replicated.The most likely cause for the reported failure of not connecting to the bluetooth/wireless can be attributed to wear and tear incurred from repetitive usage and reprocessing.Date of manufacture: 2020.

• Brand Name: SYNERGY RESECTION WIRELESS FS KIT
• 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: 20797220
• Report Number: 1220246-2024-08658
• Device Sequence Number: 7894973
• Product Code: HWE
• UDI-Device Identifier: 00888867315778
• UDI-Public: (01)00888867315778(10)12698336
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/27/2025

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 WIRELESS FS KIT
• Device Catalogue Number: AR-8315W
• Device Lot Number: 12698336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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