MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; OLIVE WIRE, THREADED

Model Number P99-201-1406

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed and met all material specifications with no deviation identified.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

It was reported that the patient underwent a calcaneal fracture surgical procedure on (b)(6) 2018 and utilized paragon 28 gorilla plating system.The 1.4mm threaded olive wire was reported to have been pre-loaded when the threaded wire slipped and pierced the plate.The tip of threaded olive wire snapped off.The initial reporter mentioned the sharp edge of the wire was protruding through the inside of the plate about 1mm.The edge of the olive that snapped was even with the outside profile of the plate.The olive wire remained stuck in the plate.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: OLIVE WIRE, THREADED
• 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: 10866015
• MDR Text Key: 219379427
• Report Number: 3008650117-2020-00168
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-201-1406
• Device Catalogue Number: P99-201-1406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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