MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; DRIVER

Model Number P99-190-TX06

Device Problem Scratched Material (3020)

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

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Case information including facility, surgeon's name, or related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.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 that utilized paragon 28 monster screw system.The 2.5mm headless screws was being implanted when two of the tx06 cannulated driver stripped.The surgeon reported that the torque was not harder than average.This is report 2 of 2 for this incident.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: DRIVER
• 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: 10865843
• MDR Text Key: 219379287
• Report Number: 3008650117-2020-00170
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K190568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-190-TX06
• Device Catalogue Number: P99-190-TX06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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