MAUDE Adverse Event Report: PARAGON 28, INC HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT, 2.75MM, 0° CANNULATED

Model Number P40-001-0275-S

Device Problems Separation Failure (2547); Unintended Movement (3026)

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

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

Information reasonably suggests this is reportable based on the time of delay associated with this event.Report 2 of 2.

Event Description

Failure of mating the part inserter and implant upon insertion.Difficulty with the inserter releasing of the implant.Report 2 of 2.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: HAMMERTUBE IMPLANT, 2.75MM, 0° CANNULATED
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 14121839
• MDR Text Key: 289505722
• Report Number: 3008650117-2022-00035
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P40-001-0275-S
• Device Catalogue Number: P40-001-0275-S
• Device Lot Number: 260B3022103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female