MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX STEPPED GUIDE CANNULA; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number AR-1510FD-24

Device Problem Corroded (1131)

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

Event Type  malfunction  

Event Description

The 2.4 arthrex stepped guide cannula is extremely rusty / corroded after only a couple of uses.The brush comes out clean when cleaning, but looking down a borescope the cannula is extremely compromised.This is the same that is happening for our 3.5 stepped guide cannulas that are happening brand new out of the box.Fda safety report id# (b)(4).

• Brand Name: ARTHREX STEPPED GUIDE CANNULA
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 9260344
• MDR Text Key: 164672886
• Report Number: MW5090778
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-1510FD-24
• Device Catalogue Number: AR-1510FD-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1