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

Model Number 133632

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.It cannot be determined how the reference sensor was assembled to the patient's tibia based on the contents of the event log, nor if this played any factor in the device output as reported by the user.The returned navigation unit and reference sensor were tested in-house.The two devices were tested by simulating a tka using saw-bones, performing a tibial and femoral navigations several times.All simulated usage passed, no issues were observed.The complaint cannot be confirmed based on the provided information.Orthalign, inc.Will continue to monitor this issue and take action when/if alert limits are exceeded.

Event Description

Inaccurate tibial alignment; the varus/valgus numbers displayed did not match actual alignment of the implant.

• Brand Name: KNEEALIGN 2 SYSTEM
• Type of Device: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656 ; 8665820879
• MDR Report Key: 12302007
• MDR Text Key: 265847605
• Report Number: 3007521480-2021-00021
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1