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.

Manufacturer Narrative

The reported event (extraction of the device due to an infection) could be confirmed, since the x-rays provided for evaluation show the infection and the extraction of the device.This conclusion was verified by a medical expert upon review of the patient's case documentation and also by the r&d expert.Since the x-rays were provided, the opinion of the medical expert was requested and stated as following: "the x-rays show the 611afn in situ with a thin radiolucent zone around it's distal half adjacent to a sclerotic line of dense bone, means that there¿s defensive bone formation.Also, there is no more a proximal screws in situ (initially implanted with the nail) and there is clear bone formation in the proximal nail chokes.Moreover, the surgeon has made a bone window by temporarily removing a piece of the tibia, to be able to get access to the implant.This piece of bone has been put back in place.Furthermore, the surgeon has split the tibial bone (the line in the axis of the tibia) to make removal possible." the opinion of the r&d expert was requested and stated as following: "in relation to the drawing of the device, there is no area on the device that will promote bone regrowth but the absence of the proximal screws could promote bone regrowth." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The root cause could not be determined.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not returned.

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: Other
• 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: Lay User/Patient
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization