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

Model Number 133632

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

An orthalign distributor reported that the reference sensor used during a total knee arthroplasty had moisture inside and that is the believed cause of the reportable complaint regarding the system accuracy.The surgeon was looked for a flexion degree of 2 and the navigation unit read 18 degrees flexion after knee movements.This is outside of the fda cleared claim of +/- 3 degrees.Once the device is returned and investigated a follow up report will be filed.Orthalign is filing this initial mdr with extreme caution while considering the risk to the patient with a device being inaccurate and the potential harm that could cause.

Event Description

Sensor has moisture inside and orthalign plus unit read 18* flexion after knee movements.

Manufacturer Narrative

The presence of moisture is suspected to be impacting the internal sensor resulting in the high degree reported on the navigation unit as described within the complaint.The unit was leak tested and found that the housing was compromised which is the root cause of the abundance of moisture present within the device.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.Mold redesign improvements for the reference sensor 2 have been initiated to address the root cause of this issue.

• Brand Name: KNEEALIGN 2
• Type of Device: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8610206
• MDR Text Key: 146351352
• Report Number: 3007521480-2019-00012
• 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
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/14/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention