MAUDE Adverse Event Report: ARTHREX, INC. APSII FOOTSWITCH, STANDARD; POWERED SURG ORTHOPEDIC INSTR

Model Number	APSII FOOTSWITCH, STANDARD
Medical Device Problem Codes	Device-Device Incompatibility (2919); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that an ar-8310 foot pedal does not work, not pairing.This was discovered during use with no patient harm.
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 is confirmed.One unpackaged ar-8310 serial/batch number (b)(6) was received for investigation.Functional testing with the testing console found that the device was not responding.Visual inspection found signs of wear and tear.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: APSII FOOTSWITCH, STANDARD
• 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: 18103848
• Report Number: 1220246-2023-08652
• Device Sequence Number: 5697918
• Product Code: HWE
• UDI-Device Identifier: 00888867043145
• UDI-Public: 00888867043145
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• 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): 01/19/2024

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: APSII FOOTSWITCH, STANDARD
• Device Catalogue Number: AR-8310
• Device Lot Number: 379920
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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