MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH; ARTHROSCOPE AND ACCESSORIES

Model Number	C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On (b)(6) 2023, it was reported by a facility representative via sems that an ar-3355-2430 scope has several black spots and a dark shadowed area in the field of view.This was discovered during an arthroscopic procedure.The case was completed by using a new scope with no patient harm.

• Brand Name: C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH
• 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: emily shafer ; 8009337001
• MDR Report Key: 17343619
• Report Number: 1220246-2023-07196
• Device Sequence Number: 6524081
• Product Code: HRX
• UDI-Device Identifier: 00888867101470
• UDI-Public: 00888867101470
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: C-MOUNT AR-SCOPE,30°,2.4X 72MM LGTH
• Device Catalogue Number: AR-3355-2430
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/18/2023
• 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
• Patient Sex: Unknown