MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; DEPTH GAUGE, 3.5 & 4.0MM SOLID SCREW

Model Number P99-150-0025

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28.Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.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

Two depth gauges was reported not measuring accurately.The monster screw system (p99-150-0025) depth gauge was said to be measuring 2 mil short and 3 mil short.The baby gorilla/gorilla plating system (p99-150-0014) was said to be measuring 4 mil short.Due to limited information, potential of harm is based on worst case-scenario for the failure mode, independent of a condition failure.This is report 1 of 2 for this incident.

Event Description

Three depth gauges were reported not measuring accurately.The monster screw system (p99-150-0025) depth gauge was said to be measuring 2 mil short and 3 mil short.The baby gorilla/gorilla plating system (p99-150-0014) was said to be measuring 4 mil short with the tip sticking out.Due to limited information, potential of harm is based on worst case-scenario for the failure mode, independent of a condition failure.This is report 1 of 3 for this incident.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: DEPTH GAUGE, 3.5 & 4.0MM SOLID SCREW
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• MDR Report Key: 11357004
• MDR Text Key: 244980399
• Report Number: 3008650117-2021-00033
• Device Sequence Number: 1
• Product Code: HTJ
• 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,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P99-150-0025
• Device Catalogue Number: P99-150-0025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: P99-150-0014; P99-150-0014; P99-150-0025