MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED

Model Number P40-002-0275-S

Device Problem Insufficient Information (3190)

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

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

The total lot quantity affected is (b)(4).Referencing (b)(4).

Event Description

Nonconforming product received; titanium plasma coating is not present on implants.The device was not used therefore there was no impact to the patient.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7207165439
• MDR Report Key: 14664089
• MDR Text Key: 300899302
• Report Number: 3008640117-2022-00064
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P40-002-0275-S
• Device Catalogue Number: P40-002-0275-S
• Device Lot Number: 26010822202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1