MAUDE Adverse Event Report: TORNIER S.A.S. 611 ANKLE FUSION NAIL RIGHT SIDE ANGLE 6 DIA. 10 LG. 180 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number LJU601

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Infection (1930)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that the surgeon wanted to schedule a revision to remove the nail from the patient. The extraction kit specific to the nail was not available to be sent to the hospital so a universal extraction kit was ordered. The surgeon could not extract the screw and the design of the titanium nail with successive narrowing at the proximal level leads to bone regrowth, making ablation impossible. The patient's lower third of the tibia had to be cut for 14cm so the nail could be removed successfully. This revision surgery was related to an infection.

• Brand Name: 611 ANKLE FUSION NAIL RIGHT SIDE ANGLE 6 DIA. 10 LG. 180
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14112180
• MDR Text Key: 289287238
• Report Number: 3000931034-2022-00154
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2018
• Device Catalogue Number: LJU601
• Device Lot Number: 8353AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/14/2022 Patient Sequence Number: 1