MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; ANKLE TIBIAL CENTER PUNCH

Catalog Number 351-10-26

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Surgeon did not cut correctly so the foot was after surgery still in varus and the tibial plate did not integrate.He needed to exchange the tibial component and the talar insert.

Manufacturer Narrative

The revision reported was likely the result of human error, as stated in the experience report provided.In the operative techniques for both the mobile bearing and fixed bearing total ankles, proper technique for addressing varus deformity and proper varus/valgus alignment of the ankle is included.See 721-00-30 and 721-00-31 for details.

• Brand Name: VANTAGE
• Type of Device: ANKLE TIBIAL CENTER PUNCH
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8514004
• MDR Text Key: 141925149
• Report Number: 1038671-2019-00241
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862290878
• UDI-Public: 10885862290878
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 351-10-26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention