MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems-06064578 that an ar-3372-2702 sheath is damaged non-specifically.This was discovered during use with no patient harm.
Additional Manufacturer Narrative
The complaint cannot be confirmed because the device cannot be visually and functionally evaluated.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 reason for the reported failure is the wear and tear damage incurred over repeated usage.Certificate of conformance manufacturing date: 01/26/2015.

• Brand Name: SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE
• Common Device Name: ARTHROSCOPE AND 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: emily shafer ; 8009337001
• MDR Report Key: 18173808
• Report Number: 1220246-2023-08818
• Device Sequence Number: 15375341
• Product Code: NBH
• UDI-Device Identifier: 00888867198494
• UDI-Public: 00888867198494
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/16/2025

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: SHEATH, 2 STOPCOCK FOR 2.7MM SCOPE
• Device Catalogue Number: AR-3372-2702
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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