MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM INTRAMEDULLARY NAIL; ORTHOPEDIC NAIL

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Malunion of Bone (4529)

Event Type  malfunction  

Manufacturer Narrative

This is the report of the second incident of two similar incidents reported by the initial reporter on 6/25/2019.Identifying information of the part, such as the part number and lot number of the device was not reported to paragon 28.Devices are not expected to be returned for the manufacturer review/investigation.Case information including the facility and surgery date was not provided by the initial reporter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a surgical procedure that utilized a phantom 4-hole intramedullary nail.After 10 weeks post-operatively, the nail was found bent and broken at the distal cuneiform hole, and it was reported that the patient displayed a non-union.No revision surgery was reported.

• Brand Name: PHANTOM INTRAMEDULLARY NAIL
• Type of Device: ORTHOPEDIC NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: mackenzie belden ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10984292
• MDR Text Key: 221514474
• Report Number: 3008650117-2020-00248
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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