MAUDE Adverse Event Report: TORNIER INC FUTURA FGT SIZE 20 IMPLANT; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number FGT-20

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent revision surgery due to experiencing dorsal subluxation.It was discovered during surgery that the prosthesis was broken into two parts.

• Brand Name: FUTURA FGT SIZE 20 IMPLANT
• Type of Device: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: mary mcnabb ; 4375 e park 30 drive; columbia city, IN 46725 ; 5743713153
• MDR Report Key: 8859875
• MDR Text Key: 191198767
• Report Number: 3004983210-2019-00043
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K981194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FGT-20
• Device Lot Number: CT0115126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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