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

Model Number ARTHREX AR-200 CONSOLE

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

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 Description

On 7/6/2023, it was reported by a sales representative via sems that an ar-200c console would not recognize the foot pedal.The icon of a cellphone with an exclamation mark came on and wouldn't go away, and the console would not work after troubleshooting.The issue was discovered during the case, and they had to connect to a tps drill to finish the case with no patient effect.This occurred during use in an unspecified procedure with no patient harm.Additional information was requested.On 8/2/2023, the sales representative provided the following information via email: this event occurred during a met osteotomy procedure on (b)(6) 2023.They kept getting the signal to call for service and attached the burr to tps to finish the case.There was no adverse effect or procedural delay reported.

• Brand Name: ARTHREX AR-200 CONSOLE
• Type of Device: 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: 17462388
• MDR Text Key: 320628402
• Report Number: 1220246-2023-07426
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867200685
• UDI-Public: 00888867200685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/04/2023

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
• Device Operator: Health Professional
• Device Model Number: ARTHREX AR-200 CONSOLE
• Device Catalogue Number: AR-200C
• Device Lot Number: 14964443
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1