MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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 01/23/2025, it was reported by a facility representative via (b)(4) that an ar-3373-4002 sheath is broken.This occurred during a case with no patient effects at all.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3373-4002 sheath batch number: 1740107 was received for investigation.Visual evaluation of the returned device noted that one of the stopcocks had broken at the weld and was no longer attached to the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated usage/reprocessing.Manufactured date: 26-may-2023.

• Brand Name: SHEATH,HF,TAP/FEN,2 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: 21373248
• Report Number: 1220246-2025-00418
• Device Sequence Number: 3772687
• Product Code: NBH
• UDI-Device Identifier: 00888867198579
• UDI-Public: (01)00888867198579(11)230526(10)1740107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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,2 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4002
• Device Lot Number: 1740107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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