MAUDE Adverse Event Report: ARTHREX, INC. ANTERIOR CANNULA, ZONENAVIGATOR, 1-PACK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ANTERIOR CANNULA, ZONENAVIGATOR, 1-PACK
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure appears to be user error, specifically the application of excessive mechanical force to the cannula, resulting in shaft bending.The complaint allegation was confirmed on the customer's attached picture, which shows the cannula of ar-7905-1 zonenavigator¿ system cannula - anterior bent.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the anterior cannula was bent after the surgeon struggled to pass the needle through the cannula.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: ANTERIOR CANNULA, ZONENAVIGATOR, 1-PACK
• 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: 23451925
• Report Number: 1220246-2025-04961
• Device Sequence Number: 18156887
• Product Code: LXH
• UDI-Device Identifier: 00888867318212
• UDI-Public: (01)00888867318212(11)240201(17)290131(10)4010137805
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/03/2025

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, 1-PACK
• Device Catalogue Number: AR-7905-1
• Device Lot Number: 4010137805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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