MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,1 STPCK FOR 4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH,HF,TAP/FEN,1 STPCK FOR 4MM SCOPE
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/11/2024, it was reported by a sales representative via (b)(4) that an ar-3373-4001 has water pouring out of the button.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-3373-4001 sheath, hf, tap/fen, 1 stopcock for 4.0 mm scope serial/batch number (b)(6) was received for investigation.Functional testing with the console and water found that the instrument is leaking by the stopcock and the black button.Visual inspection revealed that a slightly bent on the shaft, damage at the tip and signs of wear and tear.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.The device manufacturing date is dec-20-2020.

• Brand Name: SHEATH,HF,TAP/FEN,1 STPCK FOR 4MM 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: jared engle ; 8009337001
• MDR Report Key: 21112825
• Report Number: 1220246-2025-09311
• Device Sequence Number: 8718954
• Product Code: NBH
• UDI-Device Identifier: 00888867198562
• UDI-Public: (01)00888867198562(11)201230(10)1622388
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/14/2025

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,HF,TAP/FEN,1 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4001
• Device Lot Number: 1622388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown