MAUDE Adverse Event Report: SMITH AND NEPHEW ANCHOR CLEAR-TRAC COMPLETE CANNULA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72202901

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Event Description

During procedure anchor broke into pieces in patient's shoulder, all visible pieces retrieved, a new product opened and used, case completed without incident, w/o patient injury.

• Brand Name: ANCHOR CLEAR-TRAC COMPLETE CANNULA
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH AND NEPHEW ; 150 minuteman rd; andover MA 01810
• MDR Report Key: 7926201
• MDR Text Key: 122624764
• Report Number: MW5080267
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2023
• Device Catalogue Number: 72202901
• Device Lot Number: 50721228
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR