MAUDE Adverse Event Report: NEOORTHO PRODUTOS ORTOP[?]DICOS S/A NEOFIX; 900.927 - 8 HOLES 1.5 STRAIGHT PLATE

Model Number 900.927

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Date 03/23/2017

Event Type  Injury  

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 in the level of safety and effectiveness of the project.Also, it is possible to verify that during the use of the product, the plate was exposed to a loading situation different from the planned one, which caused the anticipated fracture of the material of the plate (absence of screws for fixation of the bone fracture).The unsuitable method of implant application had or contributed to a failure.

Event Description

Plate breakage 900.927, lot 3654981, 30 days after its implantation.Patient: (b)(6) years old - with proximal flange fracture of the 4th finger of the right hand, operated on (b)(6) 2017 and progress to plate breakage.Plate replacement surgery on (b)(6) 2017.Other devices used: 903,240 lot 3663832; 923.008 lot 3663802; 923.009 lot 3616173.

• Brand Name: NEOFIX
• Type of Device: 900.927 - 8 HOLES 1.5 STRAIGHT PLATE
• Manufacturer (Section D): NEOORTHO PRODUTOS ORTOP[?]DICOS S/A; angelo domingos durigan, 607; curitiba, paran[?] 82025 -100; BR 82025-100
• Manufacturer (Section G): NEOORTHO PRODUTOS ORTOPÉDICOS S/A; angelo domingos durigan, 607; curitiba, paraná 82025 -100; BR 82025-100
• Manufacturer Contact: mariana quinzani ; angelo domingos durigan, 607; curitiba, paraná 82025--100 ; BR 82025-100 ; 41 3535100
• MDR Report Key: 6541984
• MDR Text Key: 74360672
• Report Number: 3009158523-2017-00002
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07899893204038
• UDI-Public: 07899893204038
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K142419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

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
• Device Operator: Health Professional
• Device Model Number: 900.927
• Device Catalogue Number: 900.927
• Device Lot Number: 3654981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 57