MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM; PHANTOM TTC NAIL, 10.0 X 200MM, LEFT

Catalog Number P31-300-200L-S

Device Problems Difficult to Remove (1528); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Revision surgery to remove the device was successful with a significant delay to procedure.Device had been implanted without an end cap.

Manufacturer Narrative

B5 updated.H6 medical device problem updated.

Event Description

Revision surgery conducted on a nail which had been implanted without an end cap against surgical technique ran over 2 hours.Another manufacturer's explant instrumentation was used for the removal; paragon 28's explant instrumentation was not utilized.

• Brand Name: PHANTOM HINDFOOT TTC/TC NAIL SYSTEM
• Type of Device: PHANTOM TTC NAIL, 10.0 X 200MM, LEFT
• 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: 14955403
• MDR Text Key: 296579443
• Report Number: 3008650117-2022-00071
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201227
• 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,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P31-300-200L-S
• Device Lot Number: 505097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2022
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 113 KG