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

Model Number P30-R2-5548

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28.From returned images of the failure, there was a user deviation from the recommendations in the surgical technique guide.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 on (b)(6) 2019 that utilized paragon 28 phantom intramedullary nail system.The 3-hole phantom nail was reported broken post-operatively in the cuneiform area.It was said that the surgeon applied good compression over the nail before applying the final screw however, the surgeon did not use the torque indicating driver.The patient was allowed to weight bear in a boot at 3 weeks.When the surgeon saw the patient at 6 weeks, he noticed loss of compression and put the patient on a bone stim.It was reported that the patient went swimming while on vacation and at around 8 weeks post-operatively, the nail appeared broken on xray.The patient experienced mild/moderate pain.

• 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: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10880954
• MDR Text Key: 219376565
• Report Number: 3008650117-2020-00185
• 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: 11/20/2020

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-R2-5548
• Device Catalogue Number: P30-R2-5548
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 11/21/2020
• 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 Weight: 82