MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; ANKLE LOCKING CLIP, SIZE 4

Model Number ANKLE SZ 4 LOCKING CLIP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Evaluation is ongoing.The device was not explanted and therefore, will not be returned for evaluation.

Event Description

Right side implants were implanted in the patient's left ankle.

Manufacturer Narrative

The implantation of the incorrect devices reported was likely the result of human error.

• Brand Name: VANTAGE
• Type of Device: ANKLE LOCKING CLIP, SIZE 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8163871
• MDR Text Key: 130317741
• Report Number: 1038671-2018-00948
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ANKLE SZ 4 LOCKING CLIP
• Device Catalogue Number: 350-10-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/14/2018
• Date Manufacturer Received: 12/14/2018
• 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): Other
• Patient Age: 79 YR
• Patient Weight: 80