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

Model Number 133632

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

This initial report is being filed after the due date as the initial submission was found to have not been 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 initial report.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.The reference sensor and navigation unit was tested in-house by simulating a femoral maneuver using saw-bones.No issues were observed with the performance of the system.The microblock was inspected and no defects were observed.The error may reside in the user's fixation of the microblock at an initial, biased rotation, which may have provided an exaggerated measurement to the clinician.An investigation of the event log was performed.The event log reported that the user encountered difficulty in completing the femoral maneuver the first few times, but the user was able to complete the maneuver eventually.Orthalign will continue to monitor this issue and take action if or when/if alert limits are exceeded.

Event Description

It was reported that total knee arthroplasty was performed with kneealign.After maneuver leg at femur registration, surgeon adjusted angles.However, cut block position was obviously too valgous.Surgeon removed the fixation pins and inserted them to fix the cut block again.However, the same problem occurred again.Subsequently, conventional instruments were used to complete the procedure.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Type of Device: REFERENCE SENSOR 2
• 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
• MDR Report Key: 12284927
• MDR Text Key: 265432659
• Report Number: 3007521480-2019-00025
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171780
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1