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

Catalog Number 350-12-03

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Joint Disorder (2373); No Code Available (3191)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.

Event Description

Patient experienced a medial malleolar fracture and had a reoperation to place a plate on the medial side.

Manufacturer Narrative

This device is used for treatment not diagnosis.

Event Description

Patient experienced a right medial malleolar fracture.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00417, 1038671-2017-00418, and 1038671-2017-00420.

• Brand Name: TIBIAL PLATE, FB, SZ 3, RT
• Type of Device: TIBIAL PLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6672603
• MDR Text Key: 78546467
• Report Number: 1038671-2017-00419
• Device Sequence Number: 1
• Product Code: HSN
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 350-12-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention