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

Model Number P71-020-2020-S

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports (see 3008650117-2020-00013) in relation to the report of two broken staples.During evaluation and investigation, the implants were not available for analysis.The implants are not expected to be returned for the manufacturer review/investigation.The device history records were reviewed and showed that parts were manufactured and inspected within all critical specifications of the device manufacturing record.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 a paragon 28 jaws 20mm staple was implanted for a talonavicular fusion.The staple broke post-operatively at the junction of the staple bridge and leg.The broken staple was revised.The revision date, patient information, and information regarding the patient health after the implant breakage was not reported.

• Brand Name: JAWS NITINOL STAPLE SYSTEM
• Type of Device: BONE STAPLE
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood, co
• Manufacturer Contact: mackenzie belden ; 14445 grasslands dr.; englewood, co ; 6431300
• MDR Report Key: 9892142
• MDR Text Key: 188692681
• Report Number: 3008650117-2020-00012
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: P71-020-2020-S
• Device Catalogue Number: P71-020-2020-S
• Device Lot Number: 260305118A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention