MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; K-WIRE

Model Number P99-192-1615

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Identifying information of the part, such as the lot number of the device was not reported to paragon 28.Devices are not expected to be returned for the manufacturer review/investigation.The review of the device history records of the k-wire used during the surgery indicate that the device was manufactured according to specification and no deviations were noted for released product.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a triple arthrodesis surgical procedure on (b)(6) 2017 that utilized paragon 28 monster hindfoot system.A 3.5mm cannulated drill was used as an overdrill for a 5.5mm screw.During insertion of the overdrill, the 1.6 x 150mm k-wire snapped.The k-wire was reported to have broken intra-operatively during drilling.It was reported that a tissue protector was used.It was reported that the k-wire was left in the patient.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: K-WIRE
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10834200
• MDR Text Key: 217707920
• Report Number: 3008650117-2020-00135
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-192-1615
• Device Catalogue Number: P99-192-1615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• 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