MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV; ARTHROSCOPIC ACCESSORIES

Model Number	SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
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	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unpackaged ar-3373-4202 serial/batch number (b)(6) was received for evaluation.Visual inspection revealed that the stopcock was detached from the sheath at the weld, it was also noted that the sheath outside diameter was broken.Functional testing was not performed due to the damage to the device.The most likely reason for the reported failure is user error due to mishandling the device.The device¿s manufacturing date is 25-mar-2024.It is possible that the device fell or sustained blunt force damage.Refer to investigation photos.The complaint allegation is confirmed.
Event or Problem Description
On 01/02/2025 it was reported by a sales representative via (b)(4) that an ar-3373-4202 sheath stopcock fell off.This was discovered during the case with no patient harm.

• Brand Name: SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
• 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: 21255814
• Report Number: 1220246-2025-00097
• Device Sequence Number: 18407035
• Product Code: NBH
• UDI-Device Identifier: 00888867431270
• UDI-Public: (01)00888867431270(11)240325(10)1777676
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/28/2025

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,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
• Device Catalogue Number: AR-3373-4202
• Device Lot Number: 1777676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown