MAUDE Adverse Event Report: PARAGON 28, INC. JAWS NITINOL STAPLE SYSTEM; STAPLE INSERTER

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the part number and lot number of the inserter was not reported to paragon 28.Devices are not expected to be returned for the manufacturer review/investigation.The device history record of the staple 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 patient underwent a surgical procedure that utilized paragon 28 jaws nitinol staple system on (b)(6) 2020.It was reported that the surgeon experienced difficulty removing the staple inserter from the staple.As the surgeon was inserting the staple, he twisted the staple inserter in order to remove it and the dorsal cortex of the bone cracked.The staple remained in the patient and the micro-crack is expected to heal as normal.No further medical intervention was conducted.This is report 2 of 2 for this incident.

• Brand Name: JAWS NITINOL STAPLE SYSTEM
• Type of Device: STAPLE INSERTER
• 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: 10964397
• MDR Text Key: 225384870
• Report Number: 3008650117-2020-00229
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170923
• 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: 12/07/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 12/08/2020
• 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