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U.S. Department of Health and Human Services

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

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TORNIER S.A.S. 611 ANKLE FUSION NAIL RIGHT SIDE ANGLE 6 DIA. 10 LG. 180 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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.
 
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Brand Name611 ANKLE FUSION NAIL RIGHT SIDE ANGLE 6 DIA. 10 LG. 180
Type of DeviceROD, 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 Key14112180
MDR Text Key289287238
Report Number3000931034-2022-00154
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberLJU601
Device Lot Number8353AM
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? No
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
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