MAUDE Adverse Event Report: ARTHREX, INC. ZONE NAVIGATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	ZONE NAVIGATOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
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 meniscus surgery the needle could not be advanced and so the system including the ar-7905, ar-7910l and ar-7900 did not work.The surgery was finished successfully with a different device by changing to an outside-in procedure.It was not necessary to switch the general surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-7900 zonenavigator system handle serial/batch number unk was received for investigation.Functional testing with the returned ar-7905, ar-7910l, and a needle found that the device works as intended.Visual evaluation found no damaged to the device.
Additional Manufacturer Narrative
Complaint is not confirmed.One unpackaged ar-7900 zonenavigator system handle serial/batch number unk was received for investigation.Functional testing with the returned ar-7905, ar-7910l, and a needle found that the device works as intended.Visual evaluation found no damage to the device.No problem found.Complaint is not confirmed.One unpackaged ar-7900 zonenavigator system handle serial/batch number unk was received for investigation.Functional testing with the returned ar-7905, ar-7910l, and a needle found that the device works as intended.Visual evaluation found no damage to the device.No problem found.

• Brand Name: ZONE NAVIGATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16052112
• Report Number: 1220246-2022-05998
• Device Sequence Number: 17729074
• Product Code: LXH
• UDI-Device Identifier: 00888867300453
• UDI-Public: 00888867300453
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 05/03/2023

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 12/09/2022; 12/09/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 05/02/2023; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown