MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE; ARTHROSCOPIC ACCESSORIES

Model Number	SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hand surgery the tube got stuck in the hand when pulling it out and had to be removed separately.The surgery was already complete at this point.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the reported event was confirmed as one unpackaged ar-ar-3372-2402, sheath, 2 stopcock for 2.4mm scope, batch number 1576170, was received for investigation and upon visual inspection, it was observed that the weld between the main body and the shaft is broken (see evaluation picture 3).Therefore the shaft has come loose (see evaluation pictures 4 + 5).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause for the reported failure can be attributed to wear and tear due to the age of the device (manufacturing year 2019).

• Brand Name: SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
• 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24412893
• Report Number: 1220246-2026-00853
• Device Sequence Number: 10569304
• Product Code: NBH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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 2.4MM SCOPE
• Device Catalogue Number: AR-3372-2402
• Device Lot Number: 1576170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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