MAUDE Adverse Event Report: ARTHREX, INC. HIP ARTHROSCOPE HD; ACCESSORIES,ARTHROSCOPIC

Model Number 3350-4030

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  malfunction  

Event Description

Staff opened arthroscopy scope/instruments for knee scope.Scrub tech noted odd piece laying in tray.Item was the lens part of the scope where the light cord attaches.Looked like it had come unglued.

• Brand Name: HIP ARTHROSCOPE HD
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 168 brea canyon road; walnut CA 91789
• MDR Report Key: 8041165
• MDR Text Key: 126234949
• Report Number: 8041165
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2018

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
• Device Operator: No Information
• Device Model Number: 3350-4030
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2018
• Type of Device Usage: N
• Patient Sequence Number: 1