MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; TIBIAL PLATE FB SZ 3 RT

Model Number 350-12-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 350-22-41, tibial insert fb sz 1 rt 10mm.350-02-01, talar implant sz 1 rt.

Event Description

As reported, during a gastrocnemius-soleus recession under fluoroscopy procedure on this (b)(6) y/o female who is insulin dependent diabetic and has history of post traumatic arthritis, experienced a two part fracture of the medial malleolus occurred during the procedure, and was fixed with a hook plate and bone graft.Surgeon will follow up with an ae check after 3 months to determine if event is resolved.There are no devices to be returned.The clinical study case report form indicates this event is not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

(h3) upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event was a malunion of a fracture which was likely caused by over-reaming during implantation.

• Brand Name: VANTAGE
• Type of Device: TIBIAL PLATE FB SZ 3 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10458702
• MDR Text Key: 204519345
• Report Number: 1038671-2020-00506
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• Combination Product (y/n): N
• PMA/PMN Number: K152217
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 350-12-03
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86