MAUDE Adverse Event Report: ARTHREX, INC. 4K ARTHROSCOPE, 30°, 4.8 MM X 152.5 MM; ARTHROSCOPE AND ACCESSORIES

Model Number 4K ARTHROSCOPE, 30°, 4.8 MM X 152.5 MM

Device Problem Material Opacification (1426)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3350-5230 scope has a cloudy lens.It was involved in a case.Patient was not affected.

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.

Manufacturer Narrative

Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: 4K ARTHROSCOPE, 30°, 4.8 MM X 152.5 MM
• Type of Device: 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: 17314917
• MDR Text Key: 319301756
• Report Number: 1220246-2023-07134
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867216730
• UDI-Public: 00888867216730
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4K ARTHROSCOPE, 30°, 4.8 MM X 152.5 MM
• Device Catalogue Number: AR-3350-5230
• Device Lot Number: 10224117
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1