MAUDE Adverse Event Report: TORNIER SAS SALTO TALARIS TIBIAL IMPACTOR; NONE

Catalog Number MJU361

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2015

Event Type  Injury  

Event Description

The piece that goes into the tibial keeled implant broke off and went into the bone of the patient.This occurred during final implantation.The end piece of the inserter broke off during impaction and exited through the end of the tibial keeled implant, and into the bone of the patient.Patient was not harmed and there is not a need for as revision surgery.

Manufacturer Narrative

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

• Brand Name: SALTO TALARIS TIBIAL IMPACTOR
• Type of Device: NONE
• Manufacturer (Section D): TORNIER SAS; montbonnot ; FR
• Manufacturer Contact: segolene pollet ; 161 rue lavoisier; monbonnot, cedex 38334 ; 76613500
• MDR Report Key: 4656838
• MDR Text Key: 18785984
• Report Number: 9610667-2015-00014
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/24/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MJU361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 03/31/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention