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

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

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.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 lapidus arthrodesis surgical procedure on (b)(6) 2018 that utilized a paragon 28 phantom intramedullary nail.The lapidus nail was reported to have broken at the distal cuneiform hole post-operatively.The patient is said to be doing fine with some pain on the plantar fascia.The patient is using a walker and with partial weight bearing of 10-15 kg for 4 weeks.The radiographic images confirmed the break at the distal cuneiform hole.The nail is not expected to be returned and the physician does not plan on revising.

• Brand Name: PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
• Type of Device: ORTHOPEDIC NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10812098
• MDR Text Key: 219377311
• Report Number: 3008650117-2020-00110
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: 12/18/2018
• 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