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	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 it was reported by a sales representative via sems-06697273 that an ar-7300ds dissector shaver blade heated up which caused discoloration to the shaver.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted an ar-7300ds dissector shaver blade heated up which caused discoloration to the shaver.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to insufficient fluid flow during use.

• 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: 20789923
• Report Number: 1220246-2024-08633
• Device Sequence Number: 15448835
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: (01)00888867041943(11)240320(17)290228(10)15222882
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/21/2025

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: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 15222882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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