MAUDE Adverse Event Report: PARAGON 28, INC JAWS NITINOL STAPLE SYSTEM; STRAIGHT STAPLE ASSEMBLY, 18 X 18MM

Model Number P71-018-1818-S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Broken 15mm staple in the midfoot of the patient.Revision surgery was conducted on (b)(6) 2021 to remove all pieces of the staple.

• Brand Name: JAWS NITINOL STAPLE SYSTEM
• Type of Device: STRAIGHT STAPLE ASSEMBLY, 18 X 18MM
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 12547073
• MDR Text Key: 274829038
• Report Number: 3008650117-2021-00113
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P71-018-1818-S
• Device Catalogue Number: P71-018-1818-S
• Device Lot Number: 26033582005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2021
• 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): Required Intervention