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

Model Number P40-001-0275-S

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During insertion of an implant into a small bone canal the implant slid back into the inserter.An alternate procedure was utilized.This event caused a 30-45 minute extension to the procedure.

• 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: 15502160
• MDR Text Key: 300915595
• Report Number: 3008650117-2022-00117
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 260B0252201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female