MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 200329102

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, the patient underwent a total ankle replacement.It was reported that the screw broke off in the poly during insertion in the patient.The screw could not be removed from the poly and the poly was placed by hand into the patient.No additional complications were reported.

Manufacturer Narrative

H6: the product was returned for evaluation.Visual examination of the device confirms the distal threaded tip has fractured and was not returned.

• Brand Name: INBONE TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 9372156
• MDR Text Key: 168005127
• Report Number: 1043534-2019-00196
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200329102
• Device Lot Number: 754228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 03/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR