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

Model Number P99-192-1215

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28.Case information including surgery date(s), or related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.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 surgical procedure that utilized paragon 28 monster screw system.The 1.2 x 150mm k-wire was reported broken inside patient intra-operatively.The k-wire snapped off inside patient below the cortex of the bone when the drill was used over the k-wire.The end of the k-wire was removed, and a new k-wire and drill bit was used as replacement.There was no deformity with the drill.It was reported that the alignment of hand, drill, and k-wire was good and at no extreme angles.There was no revision surgery for this event and patient is said to be a non-smoker with no history of diabetes.

• 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: 10840965
• MDR Text Key: 217692531
• Report Number: 3008650117-2020-00139
• 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: 11/13/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2015
• Initial Date FDA Received: 11/13/2020
• 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