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

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

The dhr was reviewed for sterile kit p71-108-0808-s and lot 260315217b.The implant records were reviewed for part p70-108-0008, lot bdk6tc, bdk65sl, bdlc9wm, bdlc9wn, bdlv7xr, and edm-24171.The implant was measured within spec and no manufacturing or sterilization deviations were noted.The dhr for the kit p71-110-1010-s lot 260317717b was also reviewed.The implant dhrs (b)(4) were reviewed as well.The second implant measured in spec and no manufacturing or sterilization deviations were noted.

Event Description

It was reported that the patient underwent a surgical procedure for a bi-lateral akin procedure.The original surgery took place on (b)(6) 2017.According to the reporter, the first staple was not inserted flush with the bone so a second staple was then inserted.One staple broke post operatively after being implanted 4 weeks.The revision surgery took place on (b)(6) 2017.Both staples were removed during the revision surgery.During evaluation and investigation, the broken staple x-rays were evaluated and it was confirmed that the staple was broken along the proximal, angled arm.The part was not returned for physical analysis.The dhr for the sterile kits were reviewed as well as the manufacturing records for the implants used in the surgery.Both implants were manufactured according to specification with no deviations found.

• Brand Name: JAWS STAPLE SYSTEM
• Type of Device: AKIN STAPLE
• Manufacturer (Section D): PARAGON 28, INC.; 4b inverness ct e; suite 280; englewood CO 80112
• Manufacturer (Section G): PARAGON 28, INC.; 4b inverness ct e; suite 280; englewood CO 80112
• Manufacturer Contact: eric pohl ; 4b inverness ct e; suite 280; englewwod, CO 80112 ; 8557862828
• MDR Report Key: 6966424
• MDR Text Key: 89920355
• Report Number: 3008650117-2017-00002
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: P71-108-0808-S
• Device Lot Number: 260315217B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2017
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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