MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM HINDFOOT TTC/TC SYSTEM; ORTHOPEDIC INTRAMEDULLARY NAIL

Model Number P31-300-200L-S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Devices are not expected to be returned for the manufacturer review/investigation.The device manufacturing and inspection records were analyzed for the device.No deviations were noted.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 patient had an ankle arthrodesis surgical procedure using a paragon 28 phantom ttc nail.Fifteen weeks post-operatively, the nail was found broken at the coil interface.There is reported patient non-compliance.

• Brand Name: PHANTOM HINDFOOT TTC/TC SYSTEM
• Type of Device: ORTHOPEDIC INTRAMEDULLARY NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood, co
• Manufacturer Contact: mackenzie belden ; 14445 grasslands dr.; englewood, co ; 6431300
• MDR Report Key: 10291854
• MDR Text Key: 199559177
• Report Number: 3008650117-2020-00065
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191782
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P31-300-200L-S
• Device Lot Number: 5005097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention