MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPÉDICOS S/A NEOFIX; 900.353 - 12-HOLE BROAD 4.5 LS PLATE

Model Number	900.353
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It can be concluded that the product has gone through all stages of production and inspection and that the results of inspections and tests demonstrate that the product is in accordance with the safety and effectiveness of the project.Also, it is possible to verify that during the use of the product, the plate used maintained the bone alignment, but we observed a gap between the bone fragments evidencing the lack of compression as well as support between the fragments.This situation during the 4 months of implantation led to the implant fatigue.It is evident in the x-ray with the broken plate the total absence of bone callus and also that the plate have no deformation.This makes it clear that implant failure was due to fatigue caused by the lack of support between the fragments, which led to implant overload, absence of bone healing and fatigue rupture.Thus, plate rupture was due to the lack of reduction and support between the fragments, which led to the non-consolidation and overload of the implant.The unsuitable method of implant application had or contributed to a failure.
Event or Problem Description
Plate breakage 900.353, lot 3653795, about 4 months after its implantation.Patient: (b)(6) - with femur diaphysis fracture, operated on (b)(6) 2017 and progress to plate breakage.Plate replacement surgery on (b)(6) 2017.Other devices used: 903,110 lot 3642537, 903.110 lot:3622405, 903.112 lot:3646846, 901.135 lot:3637452, 901.136 lot:3655115, 901.137 lot: 3646905, 901.132 lot: 3647568, 901.134 lot: 3678916.

• Brand Name: NEOFIX
• Common Device Name: 900.353 - 12-HOLE BROAD 4.5 LS PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPÉDICOS S/A; r. angelo domingos durigan 605; curitiba, parana 82025 100; BR 82025100
• MDR Report Key: 6968769
• Report Number: 3009158523-2017-00003
• Device Sequence Number: 11035581
• Product Code: HRS
• UDI-Device Identifier: 07898624861465
• UDI-Public: 07898624861465
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: 900.353
• Device Catalogue Number: 900.353
• Device Lot Number: 3653795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2017
• Initial Report FDA Received Date: 10/23/2017
• 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: 78 YR
• Patient Weight: 69