MAUDE Adverse Event Report: ARTHREX, INC. APSII CONTROL CONSOLE; POWERED SURG ORTHOPEDIC INSTR

Model Number	APSII CONTROL CONSOLE
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the shaver was used during surgery when patient got cardiac arrhythmia.Surgeon stopped the shaver.When the surgeon used the shaver again, the cardiac arrhythmia occurred again with the patient.After second use the surgeon was finished with usage of the shaver and therefore he didn´t need to change the shaver.The patient is well.It was not necessary to switch the surgical technique or do a second surgery.***update swit 15-dec-2020: the arthrex shaver ar-8330f only influenced the ecg device in the display of conduction.The patient did not have any arrhythmias at any time.The shaver in question was replaced during the surgery.With the replacement device, there was no further change on the ecg monitor.
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.(no problem found) the evaluation did not identify any issues relevant to the reported event.

• Brand Name: APSII CONTROL 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: 18703689
• Report Number: 1220246-2024-00959
• Device Sequence Number: 7396163
• Product Code: HWE
• UDI-Device Identifier: 00888867043138
• UDI-Public: 00888867043138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K932699
• 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): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APSII CONTROL CONSOLE
• Device Catalogue Number: AR-8300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 02/14/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown