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

Model Number	APSII FOOTSWITCH, STANDARD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 02/29/2024, a facility representative reported via (b)(4) that an ar-8310 footswitch pedal wires are exposed.This was discovered during a procedure with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Functional testing was not performed on the returned ar-8310 due to the exposed wiring on the cable.Visual evaluation noticed that the cable of the device is damaged, leaving wires exposed near the end towards the footswitch.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• 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: jared engle ; 8009337001
• MDR Report Key: 18923447
• Report Number: 1220246-2024-01531
• Device Sequence Number: 6188623
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 13801081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown