MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPEDICOS S/A NEONAIL; 936.041 - FEMORAL NAIL D9X340MM

Model Number	936.041
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device lot is not distributed in the united states of america.Adverse event reported by distributor to the manufacturer on 04-sep-2019.Device lot was identified.Dhr of this lot was analyzed with no faults, including raw material.Returned device was inspected with no dimensional issues.Failure mode detected was a fracture due to fatigue.Clinical analysis was made by an orthopedic surgeon.Post-operative and pre-reoperative images show no fracture reduction was performed, no bone contact between fragments with a consequent non-fracture healing.The nail was then overloaded and fracture happened due to fatigue after 5 months.Conclusion was that the device was not responsible for the event.
Event or Problem Description
Surgery performed on (b)(6) 2019.A femoral nail d9x340mm was implanted.No complications were reported during the surgical procedure.Re operation due to pain reported by the patient on (b)(6) 2019.The femoral nail was broken on the nail distal hole.

• Brand Name: NEONAIL
• Common Device Name: 936.041 - FEMORAL NAIL D9X340MM
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPEDICOS S/A; rua angelo domingos durigan; curitiba, paraná 82025 100; BR 82025100
• MDR Report Key: 9305933
• Report Number: 3009158523-2019-00002
• Device Sequence Number: 1864719
• Product Code: HSB
• UDI-Device Identifier: 07898624868884
• UDI-Public: 07898624868884
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: Health Professional
• Device Model Number: 936.041
• Device Catalogue Number: 936.041
• Device Lot Number: 3675171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Weight: 61