MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; NITINOL ORIENTATION PIN, SINGLE ENDED TROCAR TIP, SMOOTH, 1.5MM X 200MM

Model Number P99-172-1520

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

K-wire broke during a jones fracture surgical procedure and the breakage resulted in a 40 minutes delay in surgery.

Event Description

K-wire broke during a jones fracture surgical procedure.The breakage resulted in a 40 minutes delay in surgery.No debris remains in the patient.

Manufacturer Narrative

(annex c) 4247 - this complaint was not escalated to root cause analysis.(annex d) 4316 - this complaint was not escalated to root cause analysis.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: NITINOL ORIENTATION PIN, SINGLE ENDED TROCAR TIP, SMOOTH, 1.5MM X 200MM
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7207165439
• MDR Report Key: 14739635
• MDR Text Key: 294405847
• Report Number: 3008650117-2022-00067
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-172-1520
• Device Catalogue Number: P99-172-1520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 81 KG