MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPEDICOS S/A NEOFIX; 900.313 8-HOLE 3.5 RECONSTRUCTION LS PLATE

Model Number	900.313
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the medical report and report of the medical staff, we can say that the deformation of the implant occurred due to improper use of the material.In osteosynthesis of the humeral shaft, plates that perform the function of compression and / or blocking of large fragments should be used 4.5 mm screws, since the moldable small fragments reconstruction plate, which uses 3.5mm screws, is indicated for bone reconstruction.Analyzing the radiographic images made available by the client to investigate the case.We observed signs of non-consolidation and loss of bone contact between fragments and the use of a moldable plate did not offer mechanical support to the fractured bone, failing in the purpose of fracture stabilization.The product went through all stages of production and inspection, and the results of the inspections and tests show that the product met the safety and efficacy level of the project.The plate deformation occurred due to the inadequate use of the plate, with no indication that occured structural failure of the implant in the manufacture process or raw material.
Event or Problem Description
The plate was bended after implantation.

• Brand Name: NEOFIX
• Common Device Name: 900.313 8-HOLE 3.5 RECONSTRUCTION LS PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPEDICOS S/A; rua angelo domingos durigan; curitiba, parana 82025 100; BR 82025100
• MDR Report Key: 8025510
• Report Number: 3009158523-2018-00001
• Device Sequence Number: 1755441
• Product Code: HRS
• UDI-Device Identifier: 07898624860673
• UDI-Public: 07898624860673
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 900.313
• Device Catalogue Number: 900.313
• Device Lot Number: 3655310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: 29 YR
• Patient Weight: 70