MAUDE Adverse Event Report: ARTHREX, INC. FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0'); LIGHT, SURGICAL, FIBEROPTIC

Model Number	FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of this complaint confirmed the event summary code selection and an investigation was performed as required.The complaint device was not available for investigation, however, picture(s) were provided and used for investigation.The investigation confirmed the reported condition.The probable cause of the event was determined and found to be abnormal use.Dfu-950-0031-00 for fiber optic cables warns users against direct contact of the distal end (of the device) with body tissue or flammable materials, such as drapes, as it can cause burns and fires.Based on the available information contact between the device and the patient likely occurred resulting in the reported burns.
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3200-0001t consoles monitor went dark and the fiber was hot.This occurred during an arthroscopic patellar dislocation plasty procedure on (b)(6) 2023, where the patient had a shallow second-degree skin scald with an area of about 1*0.5 cm and ulceration in the anterior upper tibial segment of the left calf.There are also two deep second-degree skin scalds and rupturing in the middle and upper segments, one with an area of 1*0.5cm and the other with an area of 2*2 cm.The wounds were caused by heat burning in the fiber.The case was completed several hours later.

• Brand Name: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• 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: 18163231
• Report Number: 1220246-2023-08792
• Device Sequence Number: 7275188
• Product Code: FST
• UDI-Device Identifier: 00888867029408
• UDI-Public: 00888867029408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Device Catalogue Number: AR-3240-5027
• Device Lot Number: WO179545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown