MAUDE Adverse Event Report: ARTHREX, INC. ZONE NAVIGATOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ZONE NAVIGATOR
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
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 during a meniscal repair surgery the device ar-7900 (lot: 15037948) didn't take the needle.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device from another manufacturer.It was not necessary to do a second surgery.Update avoe 18-oct-2023 it was confirmed that the surgery was finished successfully with a different device from another manufacturer and it was not necessary to switch the surgical procedure.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual inspection, it was noted that the ar-7900 was attached to the cannula ar-7905.No visual issues were observed on the returned zonenavigator¿ system handle.Functional testing was performed as the trigger was pushed forward until it stopped and returned to the resting position.The connector button also worked as required with the matting part returned.No problem found.

• Brand Name: ZONE NAVIGATOR
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: 18102069
• Report Number: 1220246-2023-08637
• Device Sequence Number: 7670771
• Product Code: LXH
• UDI-Device Identifier: 00888867300453
• UDI-Public: 00888867300453
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 07/31/2024

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: ZONE NAVIGATOR
• Device Catalogue Number: AR-7900
• Device Lot Number: 15037948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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