MAUDE Adverse Event Report: PARAGON 28, INC MONSTER SCREW SYSTEM; K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH, 1.2 X 150MM

Model Number P99-192-1215

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Limited information received on an mhra mir report form.

Event Description

During a procedure a k-wire broke with its debris buried within the patient's bone.The surgeon chose to leave the wire debris within the patient.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH, 1.2 X 150MM
• 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: 18890916
• MDR Text Key: 337647820
• Report Number: 3008650117-2024-00018
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-192-1215
• Device Catalogue Number: P99-192-1215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other