MAUDE Adverse Event Report: PARAGON 28, INC JAWS NITINOL STAPLE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Report 1 of 3.

Event Description

Patient non-union; staple break during patient use.

• Brand Name: JAWS NITINOL STAPLE
• Type of Device: JAWS NITINOL STAPLE
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 13252264
• MDR Text Key: 283777501
• Report Number: 3008650117-2022-00004
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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
• Patient Sex: Female