MAUDE Adverse Event Report: PARAGON 28, INC; OLIVE WIRE

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Limited information is available.Report 2 of 2 from this event.(b)(4).

Event Description

An olive wire was broken.

• Type of Device: OLIVE WIRE
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 14459677
• MDR Text Key: 293275262
• Report Number: 3008650117-2022-00055
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/20/2022
• 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