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

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

The complaint was received on 1/22/2021 however, was not deemed reportable due to the information provided by the complaint initiator.On 3/8/2021, the complaint initiator provided more information on the complaint and reported that patient injury.Reporting this incident was delayed because the reason for the event and whether patient injury occurred, was reported to manufacturer late.Investigation is ongoing and a supplemental report will be submitted upon completion.

Event Description

It was reported that the patient underwent a surgical procedure on (b)(6) 2020.The implant was reported to have broken post operatively and caused a wound on the patient, as the implant was sticking out of the patient's toe.The implant was removed on (b)(6) 2021.

Manufacturer Narrative

The complaint was received on 1/22/2021 however, was not deemed reportable due to the information provided by the complaint initiator.On 3/8/2021, the complaint initiator provided more information on the complaint and reported that patient injury.Reporting this incident was delayed because the reason for the event, and whether patient injury occurred, was reported to manufacturer late.Identifying information, such as the part number and lot number of the device was not reported to paragon 28.Dhr review was not completed because the part number and lot number was not reported.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.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: HAMMERTUBE IMPLANT
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• MDR Report Key: 11441137
• MDR Text Key: 238707214
• Report Number: 3008650117-2021-00046
• 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
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention