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

Catalog Number	350-12-03
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.Concomitant medical devices: liner (cn: 350-22-11; sn: not reported); talar (cn: 350-02-01; sn: not reported).
Event or Problem Description
Index surgery: (b)(6) 2019.Distal fibular fracture (just lateral to tibial component), which likely occurred intra-operatively.Diagnosed at 6 week post-op visit by x-ray evaluation and associated pain.No action was taken.The case report form indicates this event is definitely not related to devices and definitely related to procedure.
Additional Manufacturer Narrative
The revision reported was likely the result of a bone fracture.The reported event was a ¿distal fibular fracture (just lateral to the tibial component)¿ seen on a six-week post-operative x-ray.A review of the dhr and the sterilization records was not conducted because the event as described does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.Unintended bone fractures are listed in the device specific risks section of the vantage total ankle system ifu 700-096-157 rev -.

• 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: 8658960
• Report Number: 1038671-2019-00311
• Device Sequence Number: 2299199
• Product Code: HSN
• UDI-Device Identifier: 10885862276193
• UDI-Public: 10885862276193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 97