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

Model Number P30-L1-5548

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28 so the dhr could not be reviewed.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 that utilized a paragon 28 phantom intramedullary nail on (b)(6) 2018.The nail was reported to have broken post-operatively at the distal cuneiform hole.The patient underwent 6 weeks of non-weightbearing and was released by the surgeon 3 months post-operatively.It was reported that the patient went hiking and felt pain.The nail was found broken with a non-union.The patient was put in a boot and given bone stimulation.No revision was reported.

• 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: mackenzie belden ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10806913
• MDR Text Key: 216940752
• Report Number: 3008650117-2020-00091
• 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: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P30-L1-5548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 11/08/2020
• 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: Unknown
• Patient Sequence Number: 1