MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM INTRAMEDULLARY NAIL SYSTEM; ORTHOPEDIC NAIL

Model Number	P30-R1-5544
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implantation date was not provided by the initial reporter.The implant was removed on (b)(6) 2020 and was received by paragon 28 on 09/21/2020.The device history record was reviewed and met all material specifications with no deviations identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that nine months after implantation, a phantom 4-hole intramedullary nail broke at the distal cuneiform hole.The patient had reported pain at the area of fusion and the surgeon confirmed a nonunion at the first tarsometatarsal joint.It was reported that patient was complaint to post operative instructions provided by the surgeon.A revision surgery was completed on (b)(6) 2020 to remove the broken hardware.

• Brand Name: PHANTOM INTRAMEDULLARY NAIL SYSTEM
• Common Device Name: ORTHOPEDIC NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• MDR Report Key: 10584760
• Report Number: 3008650117-2020-00070
• Device Sequence Number: 16849553
• Product Code: HWC
• UDI-Device Identifier: 00889795039101
• UDI-Public: (01)00889795039101(10)PA656444
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: P30-R1-5544
• Device Catalogue Number: P30-R1-5544
• Device Lot Number: PA6564/44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P30-P1-3516 3.5 X 16MM LAPIDUS THREADED PEG; P30-P1-3524 3.5 X 24MM LAPIDUS THREADED PEG; P30-P1-3524 3.5 X 24MM LAPIDUS THREADED PEG; P30-S1-3518 3.5 X 18MM LAPIDUS THREADED PEG
• Outcome Attributed to Adverse Event: Required Intervention