MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; PRECISION GUIDE ARM, TIBIOTALAR JOINT, GUIDE ARM

Model Number P51-981-5001

Device Problems Mechanical Problem (1384); Output Problem (3005); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There is limited information for this complaint therefore, reportability is based on highest level of harm seen for failure mode.Identifying information, such as the lot number of the device was not reported.Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.The device history record was not reviewed because the lot number was not reported.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

A paragon 28 precision guide arm, tibiotalar joint, guide arm was reported to have failed; the pin fell off.Reasonable efforts were made to obtain case information however, the reporter was not responsive.Additional details could not be collected.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: PRECISION GUIDE ARM, TIBIOTALAR JOINT, GUIDE ARM
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112
• MDR Report Key: 11595488
• MDR Text Key: 244398630
• Report Number: 3008650117-2021-00069
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P51-981-5001
• Device Catalogue Number: P51-981-5001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: No
• 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