MAUDE Adverse Event Report: ARTHREX, INC. 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM; ARTHROSCOPE AND ACCESSORIES

Model Number	4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/31/2024 it was reported by a sales representative via sems- (b)(4) that an ar-3355-4031 arthroscope metal was broken at the hub not allowing it to screw into the camera head.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
The complaint allegation is confirmed.One unpackaged ar-3355-4031 serial/batch number (b)(6) was received for evaluation.Functional testing could not be conducted because of the lack of a mating part.A visual inspection revealed damage at the distal end of the tip.Damage to the lenses.The most likely reason for the reported failure is a user error mishandling the device.

• Brand Name: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• 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: 20054614
• Report Number: 1220246-2024-07246
• Device Sequence Number: 7955930
• Product Code: HRX
• UDI-Device Identifier: 00888867291751
• UDI-Public: 00888867291751
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• 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): 01/15/2025

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: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• Device Catalogue Number: AR-3355-4031
• Device Lot Number: 15026730
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown