MAUDE Adverse Event Report: ARTHREX, INC. FUSED LHT GD,WOLF,3.5MMX 274CM (9'); LIGHT, SURGICAL, FIBEROPTIC

Model Number	FUSED LHT GD,WOLF,3.5MMX 274CM (9')
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopic surgery the patient got burned an the area of the chest / armpit area by the blue light wire cable.The cable came in contact with the patient for a short period of time but the metal piece ( connector to the optic) became too hot and burned the patient.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: FUSED LHT GD,WOLF,3.5MMX 274CM (9')
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• 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: emily shafer ; 8009337001
• MDR Report Key: 18489212
• Report Number: 1220246-2024-00262
• Device Sequence Number: 19749469
• Product Code: FST
• UDI-Device Identifier: 00888867029392
• UDI-Public: 00888867029392
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K901035
• 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,Followup
• Report Date (Section B): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FUSED LHT GD,WOLF,3.5MMX 274CM (9')
• Device Catalogue Number: AR-3240-3527
• Device Lot Number: WO189081
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown