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

Model Number	900.927
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/23/2017
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 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 6541984
• Report Number: 3009158523-2017-00002
• Device Sequence Number: 71097
• Product Code: HRS
• UDI-Device Identifier: 07899893204038
• UDI-Public: 07899893204038
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142419
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 05/03/2017
• 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: 40 YR
• Patient Weight: 57