MAUDE Adverse Event Report: PARAGON28, INC. MONSTER SCREW SYSTEM; K-WIRE, SMOOTH, 1.2MM X 15MM

Model Number P99-192-1215

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  malfunction  

Event Description

The tip of the k-wire broke off during the procedure.The broken tip was retrieved from within the patient's joint space.However, it resulted in a total surgery delay of approximately 60 minutes.

Manufacturer Narrative

The k-wire was returned and confimed the tip was broken at the 10.5mm proximal to the tip.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: K-WIRE, SMOOTH, 1.2MM X 15MM
• Manufacturer (Section D): PARAGON28, INC.; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: kate vang ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 18818508
• MDR Text Key: 337648319
• Report Number: 3008650117-2024-00014
• 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
• Report Date: 03/01/2024

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: P99-192-1215
• Device Catalogue Number: P99-192-1215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 37 YR
• Patient Sex: Female