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 Non-union Bone Fracture (2369)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The jaws nitrol staple is still implanted in the patient and is not expected to be returned for evaluation.Alleged failure mode unable to be verfiied.If further information is identified which alters this event's conclusion, a supplemental report will be filed accordingly.

Event Description

A post market grappler interference screw pmcf study was conducted on (b)(6) 2021.A paragon 28 jaws nitinol staple implanted on (b)(6) 2020 during a talonavicular arthrodesis procedure was found to be broken across the talonavicular joint with a delayed/non-union at the 6 month follow-up visit on (b)(6) 2021.The delayed/non-union was noted to be asymptomatic for the patient and conservative treatment using an arizona brace will continue.It was noted at the 7-week post-operative visit that the patient admitted to weight-bearing some during their post-operative course due to contralateral knee problems.

• 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 ; 8557862828
• MDR Report Key: 12442566
• MDR Text Key: 270509329
• Report Number: 3008650117-2021-00106
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• 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: EDM-26360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 122