MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INFINITY TOTAL ANKLE SYSTEM

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Wright medical infinity total ankle system case 2 tray was being used for ankle surgery.Intraoperatively, as the orthopedic surgeon was trailing the implants, debris (dried matter) was noted on the metal trial.

• Brand Name: INFINITY TOTAL ANKLE SYSTEM
• Type of Device: INFINITY TOTAL ANKLE SYSTEM
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY; memphis TN 38117
• MDR Report Key: 4883775
• MDR Text Key: 6264814
• Report Number: MW5043380
• Device Sequence Number: 2
• Product Code: HSN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 64