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

Model Number	350-12-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TIBIAL PLATE FB SZ 3 RT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10458702
• Report Number: 1038671-2020-00506
• Device Sequence Number: 11302680
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 350-12-03
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86