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

Model Number N/A

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

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

Event Date 03/18/2015

Event Type  Injury  

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 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
• Type of Device: SH SELF DRILLING LOCKING SCREW
• Manufacturer (Section D): NEOORTHO; rua angelo domingos durigan; curitiba, paraná 82-02 5-10; BR 82-025-100
• Manufacturer (Section G): NEOORTHO PRODUTOS ORTOPÉDICOS S/A; angelo domingos durigan, 607; curitiba, parana 82025 -100; BR 82025-100
• Manufacturer Contact: luciana menoncin ; angelo domingos durigan, 607; curitiba, paraná 82025--100 ; BR 82025-100 ; 41 3535100
• MDR Report Key: 6541549
• MDR Text Key: 74325155
• Report Number: 3009158523-2017-00001
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07898624863216
• UDI-Public: 7898624863216
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K13733
• 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: 04/13/2017

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
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2010
• 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: 68 YR
• Patient Weight: 78