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 Codes	Overheating of Device (1437); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/20/2024, it was reported by a sales representative via (b)(4) that an ar-8315w synergy resection wireless footswitch kit when plugged with the bluetooth to the device it would state "gas pedal stuck".The bluetooth plug red light was flashing very fast and when they tried to switch out the batteries it was extremely hot.There was no case involvement, and no patient was affected.
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.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged ar-8315w / serial (b)(6) was received for investigation.Functional testing found that the device does function as required and does not display an error message when plugged in.Visual inspection noted no problems with the device.

• 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: 19546594
• Report Number: 1220246-2024-05853
• Device Sequence Number: 6711347
• Product Code: HWE
• UDI-Device Identifier: 00888867315778
• UDI-Public: 00888867315778
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/26/2024

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 WIRELESS FS KIT
• Device Catalogue Number: AR-8315W
• Device Lot Number: 12031049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/26/2024
• 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