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

Model Number	LJU601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient underwent a nail removal due to joint fusion did not occur, persistent pain in the patient.During removal the 2 anteroposterior screws broke.Half of the screw remained in the posterior part of the calcaneus as well as in the locking hole of the nail making it very complicated to remove the nail.Lengthening of more than 2 hours the duration of the intervention.The 2 pieces of screw could not be removed and were therefore left in the patient's calcaneum.The surgeon was forced to use the sledgehammer to avoid a new posterior approach, which could have further weakened the patient's calcaneus.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and x-ray provided show the breakage of the screws.Visual inspection: the extraction adaptateur is still block on the 611 ankle fusion nail.Since data and x-rays were provided, the opinion of the medical expert was requested and stated as following: the fact that the surgeon has used the 611 afn in a static locking mode could have attribut-ed to the non-union event.The fact that it is painful may refer to the (micro)motion that is occurring at the non-union site.The foot skeleton (talus and calcaneus) is moving slightly relative to the distal nail, as can be seen by the ¿impression¿ that the distal nail has made at its distal part.One of the option the surgeon would have had is to take the proximal screws out to dynam-ize the construct to generate compression at the fusion site to promote healing.It would be interesting to know how long the 611 afn has been in and if the patient was weight-bearing this side.The static fixation of the 611 afn together with the non-union will generate high stresses on the screws in particular.As in any other osteosynthesis relying on screw, they will eventually break if the bones do not unite.Most likely the screws were already damaged and were ei-ther broken already or did break easily during removal.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a static locking mode option use for this patient.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent a nail removal due to joint fusion did not occur, persistent pain in the patient.During removal the 2 anteroposterior screws broke.Half of the screw remained in the posterior part of the calcaneus as well as in the locking hole of the nail making it very complicated to remove the nail.Lengthening of more than 2 hours the duration of the intervention.The 2 pieces of screw could not be removed and were therefore left in the patient's calcaneum.The surgeon was forced to use the sledgehammer to avoid a new posterior approach, which could have further weakened the patient's calcaneus.

• Brand Name: 611 ANKLE FUSION NAIL RIGHT SIDE ANGLE 6 DIA. 10 LG. 180
• Common Device Name: 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: 15584657
• Report Number: 3000931034-2022-00343
• Device Sequence Number: 20618552
• Product Code: HSB
• UDI-Device Identifier: 03700386938276
• UDI-Public: 03700386938276
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: LJU601
• Device Catalogue Number: LJU601
• Device Lot Number: 6980AS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown