MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM; OLIVE WIRE, THREADED, 1.4MM

Model Number P99-201-1406

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

Report filed due to the possibility of serious injury based on limited information reported.

Event Description

A wire broke during surgery.

Event Description

An olive wire broke during a procedure with the wire debris remaining in the patient.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: OLIVE WIRE, THREADED, 1.4MM
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 17715772
• MDR Text Key: 323253489
• Report Number: 3008650117-2023-00108
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 07/13/2023
• 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
• Patient Outcome(s): Other