MAUDE Adverse Event Report: EXACTECH, INC. ANKLE - IMPLANT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number ANKLE - IMPLANT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, surgeon had a locking clip disengage in one of his patients.No additional information provided.

Manufacturer Narrative

Section h3: the disassembled vantage total ankle locking clip reported was likely the result of the locking clip not being fully engaged at the time of initial surgery, allowing the clip to disengage over time.However, this cannot be confirmed because the devices were not available for evaluation and adequate information was not provided.The most probable root cause for the reported event "disassembled / misassembled" is associated with the unwanted disassembly of the device, or incorrect assembly of the device (attaching mating instrumentation incorrectly, assembling an implant construct off-axis, etc.).

• Brand Name: ANKLE - IMPLANT
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17270952
• MDR Text Key: 318560795
• Report Number: 1038671-2023-01570
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: ANKLE - IMPLANT
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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