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

Model Number ANTERIOR CANNULA, ZONENAVIGATOR, 1-PACK

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

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 Description

It was reported that during a meniscus repair surgery the needle did not go through the anterior cannula of the zone navigator, not even with force.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: ANTERIOR CANNULA, ZONENAVIGATOR, 1-PACK
• Type of Device: 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: 18444696
• MDR Text Key: 331986403
• Report Number: 1220246-2024-00088
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867318212
• UDI-Public: 00888867318212
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANTERIOR CANNULA, ZONENAVIGATOR, 1-PACK
• Device Catalogue Number: AR-7905-1
• Device Lot Number: 2215124037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1