MAUDE Adverse Event Report: PARAGON 28, INC; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problems Break (1069); Separation Failure (2547)

Patient Problem Implant Pain (4561)

Event Date 02/15/2023

Event Type  Injury  

Event Description

A ttc nail removal due to patient pain was planned.During the nail removal procedure, the surgeon experienced difficulty with the end cap as it had been cross threaded during implantation.The end cap was unable to be removed to aid in the nail's removal.As a result, the nail coil was broken; its debris remains in the patient.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 16566635
• MDR Text Key: 311513481
• Report Number: 3008650117-2023-00054
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• 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): Other
• Patient Sex: Female