MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2 SYSTEM; REFERENCE SENSOR

Model Number 133632

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

A femur osteotomy was performed per angles provided by the kneealign 2 system as the sensor couldn't register the hip rotation accurately, resulted in valgus cut of the femur.At this time there is no known injury to the patient.Once the product is returned orthalign will perform an investigation into the alleged accuracy issue.Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that could be caused to the patient by an inaccurate device measurement.

Event Description

It was reported that the sensor couldn't register the hip rotation accurately.Resulted in valgus cut on the femur.

Manufacturer Narrative

An investigation of the returned reference sensor found the housing had broken where the mounting bracket is attached; this caused an angular offset which resulted in incorrect registration angles.Mold redesign improvements for the reference sensor 2 have been initiated to address the root cause.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.

• Brand Name: KNEEALIGN 2 SYSTEM
• Type of Device: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo, ca
• MDR Report Key: 10186640
• MDR Text Key: 201014115
• Report Number: 3007521480-2020-00008
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (y/n): N
• PMA/PMN Number: K163379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention