MAUDE Adverse Event Report: TORNIER S.A.S. 611 ANKLE FUSION NAIL

Model Number NAIL RIGHT A6° D10 L180

Device Problem Failure to Eject (4010)

Patient Problem No Information (3190)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a surgery in order to remove a nail at the ankle, the surgeon notices that one of the screws locking the nail seems "welded".The surgeon was unable to perform the planned operation and had to perform a tibia osteotomy requiring an additional surgical approach as well as an increased duration of operation.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: 611 ANKLE FUSION NAIL
• Type of Device: 611 ANKLE FUSION NAIL
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8354126
• MDR Text Key: 136853151
• Report Number: 3000931034-2019-00030
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03700386938276
• UDI-Public: 03700386938276
• 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: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: NAIL RIGHT A6° D10 L180
• Device Catalogue Number: LJU601
• Device Lot Number: 3400AN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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): Other