MAUDE Adverse Event Report: ARTHREX, INC. SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
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 (b)(6) 2024, it was reported by a facility representative via (b)(4) that an ar-3371-4000 sheath body¿s end looks beat up and is catching soft tissue.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3371-4000 serial/batch (b)(6) was received for investigation.Visual inspection noted that the shaft was damaged: gauges and striation marks.Additionally, the stopcock was not returned.Functional testing was not performed due to the damage to the device.The most likely cause is attributed to misuse due to prying/leveraging the device during use.

• Brand Name: SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
• 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: 20278135
• Report Number: 1220246-2024-07798
• Device Sequence Number: 12759270
• Product Code: NBH
• UDI-Device Identifier: 00888867030145
• UDI-Public: 00888867030145
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/07/2025

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 BODY, TAP/FEN, HF/4MM SCP STH SYS
• Device Catalogue Number: AR-3371-4000
• Device Lot Number: 1634615
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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