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

Model Number P30-L1-5542

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

Devices are not expected to be returned for the manufacturer review/investigation.Identifying information, such as the lot number of the nail, was not reported to paragon 28.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 a paragon 28 phantom nail broke post operatively.The patient was said to have had repeated nonunion at the 1st metatarsocuneiform fusion.The radiographic image revealed the fracture of the lapidus nail in the 4th metatarsocuneiform joint fusion site.At this time there has been no revision surgery because the nail provides some stability.

• Brand Name: PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
• Type of Device: ORTHOPEDIC INTRAMEDULLARY NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112
• MDR Report Key: 10782696
• MDR Text Key: 216322075
• Report Number: 3008650117-2020-00077
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P30-L1-5542
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• 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
• Patient Age: 53 YR