MAUDE Adverse Event Report: PARAGON 28, INC. APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM; PEG PUNCH

Model Number P10-951-TPL3

Device Problems Difficult to Insert (1316); Defective Component (2292)

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

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 surgical procedure for an end state arthritis condition that utilized paragon 28 apex 3d total ankle replacement system.The initial reporter stated that the surgeon was unable to insert the tibia peg punch into the an already punched holes using the viper tip punch.The part was reported not manufactured to the correct size and would not punch the tibial peg holes in the proper location if used.The part was not used to complete the tibial peg holes.The patient suffered no injury.

• Brand Name: APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM
• Type of Device: PEG PUNCH
• 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: 11168602
• MDR Text Key: 227987834
• Report Number: 3008650117-2021-00009
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192994
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P10-951-TPL3
• Device Catalogue Number: P10-951-TPL3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR