MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-200 CONSOLE; POWERED SURG ORTHOPEDIC INSTR

Model Number	ARTHREX AR-200 CONSOLE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On 11/10/2023, it was reported by a sales representative via (b)(4) that an ar-200m motor with cable 3.5m was not recognized on the console and the customer had to be opened up instead of doing minimally invasive surgery.This was discovered during an unspecified procedure.Additional information received on 11/14/2023: this was discovered during a mis bunion procedure.Instead of doing minimally invasive surgery, the incision was required to be opened, and the bone was excised with a rongeur and a saw.The patient's quality of life was not reduced; healing time and outcome of the surgery may have been affected.The case was completed by opening the incision and reverting to an open procedure.There was a reported 30-45 minute delay in the procedure.There was no additional anesthesia administered.The patient's health status was stated as "okay.".
Additional Manufacturer Narrative
The complaint allegation cannot be confirmed as the device was not received for evaluation, and no pictures of the failure were received.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error.Specifically, the error involved not performing a test before use.Direction for use.Dfu-0225-eor1_fmt_en.General warnings and safety notices - read this first.Important safety conventions.6.Perform a test run before each use.All couplings and mechanical connections need to be fully secured or locked before the actuation of the system.

• Brand Name: ARTHREX AR-200 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: emily shafer ; 8009337001
• MDR Report Key: 18282184
• Report Number: 1220246-2023-09253
• Device Sequence Number: 15018682
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARTHREX AR-200 CONSOLE
• Device Catalogue Number: AR-200C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown