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

Model Number	ARTHREX AR-200 CONSOLE
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that an error message was displayed on the ar-200c (sn (b)(6)) during the use of the ar-200m (sn (b)(6)).There was no harm or adverse event for patient, operator or third party reported.No parts broke inside the patient.The minimally invasive distal metatarsal osteotomy (dmmo) surgery was finished successfully with a new device from stryker.A switch of the surgical technique was necessary, as a different device was used.It was not necessary to do a second surgery.Update avoe 01-feb-2021: they couldn't operate the patient with the device at all, because the device didn't work at all.No larger or new incisions were necessary in the patient due to the use of the stryker devices, since an arthrex burr was also used.The duration of the operation increased by 5-10 min due to the defect.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.

• 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: jared engle ; 8009337001
• MDR Report Key: 19474039
• Report Number: 1220246-2024-05011
• Device Sequence Number: 3931075
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/06/2024

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: ARTHREX AR-200 CONSOLE
• Device Catalogue Number: AR-200C
• Device Lot Number: 10949951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• 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
• Patient Sex: Unknown