MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, SJ 3.0MM X 7CM; SAW BLADE

Model Number	DISSECTOR, SJ 3.0MM X 7CM
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.The customer's photo evaluation of the alleged ar-7300ds, attached to the complaint, revealed that the device's tip was severely burned.The inner tube might have sustained damage from the burn as well.The most probable cause of the reported failure is user error due to operating the device without irrigation flow.According to dfu-0215 at revision 1.F.Precautions.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.
Event or Problem Description
On 08/08/2024, an arthrex subsidiary employee reported via sems (b)(4) that an ar-7300ds dissector had an issue during testing.The surgeon performed the oscillation back and forth without any problem.It was then passed to the assistant, who made it work again.The tip then turned bright red and had sparks, causing the device to be burned and inoperative (see photo attached).This was discovered before use during a hand arthroscopy procedure on (b)(6) 2024, with no reported harm to the patient, surgeon, or the facility's staff.Additional information was received on 09/02/2024: the ar-7300ds dissector was connected to the shaver handpiece and the shaver console during the event.No harm was confirmed to the patient, surgeon, or the facility's staff.

• Brand Name: DISSECTOR, SJ 3.0MM X 7CM
• Common Device Name: SAW BLADE
• 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: 20144501
• Report Number: 1220246-2024-07368
• Device Sequence Number: 8301789
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 15077947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown