MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN2 SYSTEM - REFERENCE SENSOR 2; SURGICAL NAVIGATION SYSTEM

Model Number 133632

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

At this time, the devices in question have been requested to be returned for investigation.If the devices are received, an investigation will be performed to confirm the problem and determine root cause, and a followup report will be filed detailing the conclusions.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by device inaccuracy.

Event Description

Surgeon reported that he is unhappy with the information/values being given for the femoral side, and he believes there is a fault with the sensors.

Event Description

Surgeon reported that he is unhappy with the information/values being given for the femoral side, and he believes there is a fault with the sensors.Updated information from the orthalign contact reports that after registering the hip center and placing the curring block in zero def.To mechanical axis, that the technology was putting the surgeon in severe valgus or varus, which wouldn't make sense.

Manufacturer Narrative

The device was returned to orthalign for evaluation.The investigation was performed by the orthalign engineer was not able to replicate the reported event.No issues were found with the returned rs2 unit.Its is suspected the user's instrumentation (specifically the microbock) which was not returned for investigation may have contributed to the complaint event.This complaint cannot be confirmed and no root cause can be determined.A full evaluation summary is attached and orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: KNEEALIGN2 SYSTEM - REFERENCE SENSOR 2
• Type of Device: SURGICAL NAVIGATION SYSTEM
• 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: 16820892
• MDR Text Key: 314086004
• Report Number: 3007521480-2023-00007
• 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: K163379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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: Health Professional
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1