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

Catalog Number 0020600

Device Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/07/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a post operative complication of fracture displacement.Patient id: (b)(6).No other effects noted in report.

• Brand Name: AEQUALIS HUMERAL NAIL SYSTEM
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 8132540
• MDR Text Key: 129305698
• Report Number: 3004983210-2018-00077
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0020600
• Device Lot Number: CA5207811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2018
• 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: 69 YR