MAUDE Adverse Event Report: ARTHREX, INC. 4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM; ARTHROSCOPE AND ACCESSORIES

Model Number	4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
No complaint allegation was provided.There was no harm for patient, operator or third party reported.No further information was received.Update dw 12-feb-2025: further information was provided that during a surgery it was found that nothing could be seen through the used optic.As no replacement device was available the customer had to abort the surgery and the patient had to be awakened.Update dw 13-feb-2025: it was further reported that the reported device stopped working during a knee surgery on the meniscus.It is not known if the patient received an additional treatment.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the reported event was confirmed.The manufacturer evaluation revealed the device shows signs of heavy use.Furthermore, the distal end is very badly damaged and there are broken lenses in the system which indicates the device has not been used properly.

• Brand Name: 4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM
• 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: 21396586
• Report Number: 1220246-2025-00469
• Device Sequence Number: 18086488
• Product Code: HRX
• UDI-Device Identifier: 00888867291690
• UDI-Public: (01)00888867291690(11)220110(10)14919665
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080560
• 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): 07/03/2025

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: 4K ARTHROSCOPE, 30°, 4 MM X 152.5 MM
• Device Catalogue Number: AR-3350-4031
• Device Lot Number: 14919665
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown