MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; PIN

Model Number P40-002-0275-S

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Case information including facility, or related patient information was not provided by the initial reporter.Devices was returned and received on 02/01/2019 for the manufacturer review/investigation.The k-wire appears to have been drilled through the middle of the implant.The implant was reviewed and confirmed to have passed all material and design specification before release for distribution.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 surgical procedure in (b)(6) 2018 that utilized paragon 28 hammertube implant.At 7 weeks post operatively, upon the removal of the k-wire, the implant came out as well.The use of k-wire is for additional stability across the joint.It was reported that the patient's toe does not show any displacement and the patient is reported to be doing well.The physician does not plan on revising.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: PIN
• 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: 10814618
• MDR Text Key: 217089305
• Report Number: 3008650117-2020-00115
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K171715
• 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: 11/09/2020

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: P40-002-0275-S
• Device Catalogue Number: P40-002-0275-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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