MAUDE Adverse Event Report: TORNIER S.A.S. SALTO TALARIS TIBIAL INSERT; ANKLE PROTHESIS

Model Number	SIZE 2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported the loosening of the tibial component and posterior migration associated with insert disconnection from tibial baseplate with most likely fracture of insert at less than 1 month post op.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported the loosening of the tibial component and posterior migration associated with insert disconnection from tibial baseplate with most likely fracture of insert at less than 1 month post op.

• Brand Name: SALTO TALARIS TIBIAL INSERT
• Common Device Name: ANKLE PROTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5986435
• Report Number: 3000931034-2016-00153
• Device Sequence Number: 1917228
• Product Code: HSN
• UDI-Device Identifier: 03700386926792
• UDI-Public: 03700386926792
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2016

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: 02/23/2021
• Device Model Number: SIZE 2
• Device Catalogue Number: LJU265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other