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

Model Number	ARTHREX AR-200 CONSOLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
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.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 (b)(6) 2023, it was reported by a sales representative via sems that an oem06202400 footswitch s-n1 and an ar-200c console had an issue.During a case on (b)(6) 2026, the console stopped detecting the footswitch.The console somehow got a sizable crack in the input, and a pin in the footswitch broke off as well, likely due to the faulty console.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On (b)(6) 2023, the sales representative provided the following information: this occurred during an mis bunionectomy procedure.When the console did not recognize the footswitch, the message displayed was a ¿?¿ and an image of the footswitch.The osteotomy was completed with an mis burr placed in a tpx burr.There was a 10-minute delay as they attempted to fix the console, and no adverse effect to the patient or outcome.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.(1) unpackaged ar-200c console for drillsaw highspeed 200 system was returned for investigation.The returned device was visually inspected, and it was noted that the footswitch connector was damaged.No functional test performed for this device with a damaged connector.The most likely cause for the reported failure is a user error.

• 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: 17610282
• Report Number: 1220246-2023-07604
• Device Sequence Number: 12603803
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/06/2024

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: 14964443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/06/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown