MAUDE Adverse Event Report: FILLAUER NORTH CAROLINA FILLAUER INTERLOCK JOINT; INTERLOCK LEFT MEDICAL CONTOUR JOINT 16MM 5/8" BAR

Model Number IL-58JL

Device Problems Fracture (1260); Failure to Align (2522); Patient-Device Incompatibility (2682); Misassembled During Installation (4049)

Patient Problem Limb Fracture (4518)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

Please note this is the manufacturer's first electronic submission.There were some delays in the electronic account setup process which led to delays in submission of this report.Please see attachment for full manufacturer's narrative.

Event Description

The patient has post polio and has been using a kafo for some time.The patient was walking in their garage to their car, heard 2 pops, and fell.The patient was using an assistive walking device (cane) at this time.Both orthotic knee joints broke.The patient did not initially know the extent of the injury and only when the discomfort persisted did they go to the hospital.At the hospital they confirmed a left distal femur fracture.The patient was admitted to the hospital for surgery to pin the femur.The patient will not be walking for several weeks.According to the practitioner, the patient primarily uses a scooter during their daily activities but will often use a cane at home.The patient has had no changes to their weight, activity, or progression of polio over the last several months.The patient does not work and is not a high activity patient.

• Brand Name: FILLAUER INTERLOCK JOINT
• Type of Device: INTERLOCK LEFT MEDICAL CONTOUR JOINT 16MM 5/8" BAR
• Manufacturer (Section D): FILLAUER NORTH CAROLINA; weaverville NC
• Manufacturer (Section G): FILLAUER NORTH CAROLINA
• Manufacturer Contact: annette cole ; 2710 amnicola highway; chattanooga, TN 37406 ; 4236240946
• MDR Report Key: 17591694
• MDR Text Key: 321620456
• Report Number: 1036132-2023-00001
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IL-58JL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BECKER DOUBLE ACTION ANKLE JOINTS; CANE; FILLAUER LEVER RELEASE KIT (LARGE)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 73 KG