MAUDE Adverse Event Report: ARTHREX, INC. ANTERIOR CANNULA, ZONENAVIGATOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ANTERIOR CANNULA, ZONENAVIGATOR
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 7th feb 2026, it was reported by an arthrex's employee via an email that for 2 units of ar-7905, zonenavigator¿ system cannula - anterior, ve5, the meniscus needle could not go through both the cannula (refer to video).This was detected during a medial meniscus repair (bucket handle tear) on (b)(6) 2026.The procedure was completed successfully by using ar-7910r instead.There was no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: ANTERIOR CANNULA, ZONENAVIGATOR
• 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: jared engle ; 8009337001
• MDR Report Key: 24432875
• Report Number: 1220246-2026-00902
• Device Sequence Number: 13338137
• Product Code: LXH
• UDI-Device Identifier: 00888867300460
• UDI-Public: (01)00888867300460(11)250101(17)291231(10)5002155552
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 06/12/2026

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: ANTERIOR CANNULA, ZONENAVIGATOR
• Device Catalogue Number: AR-7905
• Device Lot Number: 5002155552
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown