MAUDE Adverse Event Report: PARAGON28, INC PARATROOPER PLANTAR PLATE REPAIR SYSTEM; PARATROOPER PLANTAR PLATE REPAIR SYSTEM, IMPLANT ONLY KIT- STERILE

Model Number	P13-000-5016-S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Two sets of the paratrooper shuttle anchor detached from the shuttle strands while the surgeon attempted to pull the implant through the bone tunnel.The hospital's suture was utilized to suture and anchor to the plantar plate.All debris was successfully removed but surgery was delayed by 45 minutes.This is report 1 of 2 for the first set.

• Brand Name: PARATROOPER PLANTAR PLATE REPAIR SYSTEM
• Common Device Name: PARATROOPER PLANTAR PLATE REPAIR SYSTEM, IMPLANT ONLY KIT- STERILE
• Manufacturer (Section D): PARAGON28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: kate vang ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 18580197
• Report Number: 3008650117-2024-00004
• Device Sequence Number: 7030582
• Product Code: MBI
• UDI-Device Identifier: 00889795118479
• UDI-Public: 00889795118479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P13-000-5016-S
• Device Catalogue Number: P13-000-5016-S
• Device Lot Number: 9455507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female