MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE LOCKING CLIP

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to infection.

Manufacturer Narrative

Revision due to infection, likely caused by having a fresh wound at a music festival for a few days.Engineering evaluation noted that the revision reported was likely the result of an infection caused by an open wound.Infection is addressed in the product labeling under general surgical risks.

• Brand Name: VANTAGE LOCKING CLIP
• Type of Device: LOCKING CLIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66rh court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 7957700
• MDR Text Key: 123485714
• Report Number: 1038671-2018-00803
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2018
• 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): Required Intervention