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

Model Number P31-315-200L-S

Device Problem Unintended Movement (3026)

Patient Problem Limb Fracture (4518)

Event Date 10/09/2021

Event Type  Injury  

Manufacturer Narrative

Captured the kit level information.The nail only part number is p31-315-200l with lot number pa2019004625.

Event Description

The ttc nail was found to be broken however the surgeon decided to monitor the situation instead of an immediate revision.It was reported the patient was overweight, non-compliant, and fell in the shower 4 days later.Patient suffered a serious injury and revision surgery was completed the same day.

• Brand Name: PHANTOM HINDFOOT TTC/TC NAIL SYSTEM
• Type of Device: PHANTOM TTC NAIL
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• MDR Report Key: 12738168
• MDR Text Key: 279590329
• Report Number: 3008650117-2021-00126
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K201227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P31-315-200L-S
• Device Catalogue Number: P31-315-200L-S
• Device Lot Number: 5005105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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
• Patient Age: 63 YR