MAUDE Adverse Event Report: ARTHREX, INC. INNER SHEATH FOR PANO SCOPE, PART A; ARTHROSCOPIC ACCESSORIES

Model Number	INNER SHEATH FOR PANO SCOPE, PART A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause of the issue.This cause appears to be related to misuse, specifically prying or leveraging the device with excessive force.
Event or Problem Description
On 10/27/2025, it was reported by a sales representative via (b)(4) that an ar-3370-4203a inner sheath broke in half.Noticed during a case, device swapped, and case completed with no patient effect.

• Brand Name: INNER SHEATH FOR PANO SCOPE, PART A
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 23547198
• Report Number: 1220246-2025-05071
• Device Sequence Number: 9322926
• Product Code: NBH
• UDI-Device Identifier: 00888867431348
• UDI-Public: (01)00888867431348(11)250129(10)1817093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/13/2025

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: INNER SHEATH FOR PANO SCOPE, PART A
• Device Catalogue Number: AR-3370-4203A
• Device Lot Number: 1817093
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown