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	09/26/2024
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, a sales representative reported via (b)(4) that ar-8330h sn (b)(6) - buttons don¿t work when plugged into console.Discovered during a case, no adverse affects on patient.Pump remote ar-6482 sn (b)(6) - certain buttons don¿t work, run/stop or pressure down.Discovered during a case, no adverse affects on patient.Scope ar-3350-4030 sn (b)(6) - scratch and/or crack on lens.Discovered during a case, no adverse affects on patient.Sheath ar-3373-4002 sn lot# (b)(6) - (sales order (b)(4) weld is broken, pictures attached.Discovered during a case, no adverse effects on patient.Foot pedal ar-8310 sn (b)(6) - pedals not working.Discovered during a case, no adverse effects on patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3373-4002 sheath batch number: 1458937 was received for investigation.Visual evaluation of the returned device noted that the laser markings were heavily faded.Scratches and nicks were observed throughout the surface of the device, notably on the tip of the shaft.It was further noted that the shaft was no longer attached to the device and would disassemble easily.Functional testing was unable to be 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.Date of manufacture: 31-jul-2017.

• 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: 20369501
• Report Number: 1220246-2024-07998
• Device Sequence Number: 6925880
• Product Code: NBH
• UDI-Device Identifier: 00888867198579
• UDI-Public: (01)00888867198579(11)170731(10)1458937
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/04/2025

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: 1458937
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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