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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/11/2024, it was reported by a sales representative via (b)(4) that an ar-3373-4001 sheath end has been sawed in half.This occurred during use in a case with no patient effect.
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.One unpackaged ar-3373-4001 sheath batch number: 1646612 was received for investigation.Visual evaluation of the returned device noted significant damage to the shaft of the device, the tip was scratched and bent.Further visual inspection noted wear and tear to the returned device with faded laser markings and a faded black button.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• 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: 21112830
• Report Number: 1220246-2025-09310
• Device Sequence Number: 12941456
• Product Code: NBH
• UDI-Device Identifier: 00888867198562
• UDI-Public: (01)00888867198562(11)210614(10)1646612
• 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): 03/28/2025

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,HF,TAP/FEN,1 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4001
• Device Lot Number: 1646612
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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