MAUDE Adverse Event Report: ARTHREX, INC. MID/POST CANNULA, LEFT, ZONENAVIGATOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MID/POST CANNULA, LEFT, ZONENAVIGATOR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/31/2025, it was reported by a sales representative via sems-(b)(4) that an ar-7910l mid/post cannula was disconnected from the plastic grey part and unable to use.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: MID/POST CANNULA, LEFT, 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: 21875681
• Report Number: 1220246-2025-01613
• Device Sequence Number: 8741899
• Product Code: LXH
• UDI-Device Identifier: 00888867300477
• UDI-Public: (01)00888867300477(11)220301(17)270228(10)2042119414
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: MID/POST CANNULA, LEFT, ZONENAVIGATOR
• Device Catalogue Number: AR-7910L
• Device Lot Number: 2042119414
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown