MAUDE Adverse Event Report: NEOORTHO NEOFIX; SH SELF DRILLING LOCKING SCREW

Model Number	N/A
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	03/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One (1) unit - 901 185 - 800 010 691 lot.Two (2) units - 901 183 - lot 3608694.One (1) unit - 901 183 - lot 3618229.The screws and plate were produced in accordance with the specified / projected.There is no evidence that the failure has occurred by material fail.Conclusion: the material failure occurred by the use of only four (4) screws in the distal part of the plate (900.502).And also because of the distal femur of the patient compromised by the presence of the knee prosthesis and intramedullary bone cement and releasing the load before signs of consolidation display region.
Event or Problem Description
In a surgery performed, a 5-hole left less invasive distal femur plate was implanted, approximately two months after the procedure the patient returns for another surgery because the distal femur plate was loose and had broken fixing screws.

• Brand Name: NEOFIX
• Common Device Name: SH SELF DRILLING LOCKING SCREW
• Manufacturer (Section D): NEOORTHO; rua angelo domingos durigan; curitiba, paraná 82-02 5-10; BR 82-025-100
• MDR Report Key: 6541549
• Report Number: 3009158523-2017-00001
• Device Sequence Number: 616568
• Product Code: HWC
• UDI-Device Identifier: 07898624863216
• UDI-Public: 7898624863216
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K13733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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 Expiration Date: 07/20/2025
• Device Model Number: N/A
• Device Catalogue Number: 901.185
• Device Lot Number: 80010691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2015
• 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: 68 YR
• Patient Weight: 78