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

Model Number	APSII CONTROL CONSOLE
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
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
It was reported that with the attached handpiece the screen showes that it is not connected.There was no harm for patient, operator or third party.No further information received.
Additional Manufacturer Narrative
Additional info: h6.The device was not received; therefore, an evaluation on the product could not be performed.The reported event cannot be verified.A most likely cause for the reported event was attributed to wear and tear.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17709945
• Report Number: 1220246-2023-07819
• Device Sequence Number: 15136264
• Product Code: HWE
• UDI-Device Identifier: 00888867043138
• UDI-Public: 00888867043138
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 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: 08/15/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2014
• 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