MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOPEDICOS S/A NEOFIX; 900.312 - 6-HOLE 3.5 RECONSTRUCTION LS PLATE

Model Number	900.312
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Technical analysis of material: an analysis of the dhr of item 900.312, lot 3657124 was made.The information contained in the dhr demonstrates that the product has correctly followed the production steps, with inspection records of the indicated quotas during the process and the records of these measurements indicate that the results are within the specified, as established in the control plan.Sales history: a total of (b)(4) plates of the 900.312 code were marketed and this was the only case reported for this failure mode.Analysis of the failure mode: according to the technical report of analysis prepared by the engineering department of neoortho and doctor report issued by the clinical consultant dr.(b)(6), we can affirm that the implant failure occurred due to the inadequate use of the material, according to the justifications presented below.In the treatment of radius fracture or pseudoarthrosis, plates that perform the compression and blocking function, such as the plate used in the ulna of this patient, should be used, since the common muscular movements and forces in this region generated tension in the plate, superior to its resistance defined by design.After plate analysis sent by the distributor, we can verify that the fracture presents clear signs of a type of metal fracture called "low cycle fatigue fracture" composed of a more worn region where the fracture started and, later, a "cleaner" region where the fracture occurred quickly due to the decrease in the resistant section of the plate.Conclusion: it is concluded, therefore, that the product has gone through all the stages of production and inspection planned, and the results of the inspections and tests demonstrate that the product met the level of safety and efficacy established in the project.With this, we can affirm that the plate rupture occurred due to the inadequate use of the plate, with no indication that there was structural failure of the implant, in its manufacture or raw material.
Event or Problem Description
Patient has been in the postoperative for several months.Upon returning to the doctor, the plate 930.312, lot 3657124 was broken.(b)(6) submitted to a surgical procedure for implantation of neoortho material on (b)(6) 2018 and on (b)(6) 2018 the broken implant was removed.The manufacturer was informed by the distributor on january 31, 2019.

• Brand Name: NEOFIX
• Common Device Name: 900.312 - 6-HOLE 3.5 RECONSTRUCTION LS PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOPEDICOS S/A; rua angelo domingos durigan; curitiba, parana 08202 5100; BR 082025100
• MDR Report Key: 8373425
• Report Number: 3009158523-2019-00001
• Device Sequence Number: 2127390
• Product Code: HRS
• UDI-Device Identifier: 07898624860642
• UDI-Public: 07898624860642
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 900.312
• Device Catalogue Number: 900.312
• Device Lot Number: 3657124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/27/2019
• 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: 50 YR
• Patient Weight: 93