MAUDE Adverse Event Report: TORNIER INC. AEQUALIS HUMERAL NAIL SYSTEM; INTRAMEDULLARY NAIL

Catalog Number 0020500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

It was reported that a patient underwent an arthroscopic debridement on (b)(6) 2017 due to post-operative stiffness and range of motion loss followed by a corticosteroid injection on (b)(6) 2017.

• Brand Name: AEQUALIS HUMERAL NAIL SYSTEM
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue south; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 7269436
• MDR Text Key: 99997898
• Report Number: 3004983210-2018-00002
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 0020500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 111