MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; ORTHALIGN PLUS NAVIGATION UNIT

Model Number	403001-05
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation of returned navigation unit log file found the femoral axis registration numbers were beyond typical numbers.The user received the jig out of range error several times until the jig was re-pinned.The numbers indicate the jig was likely pinned too high or incorrectly, this is further supported by the fact the user selected an a/p offset of 1 which is the minimum amount.If the true a/p offset was a higher number, the output would have been closer to a nominal case.Root cause was unable to be determined for this complaint but since the behavior described is shown in the log file, the complaint can be confirmed.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.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.
Event or Problem Description
It was reported that after femoral registration the unit read 24 degrees of flexion.Femoral pin was reinserted and range of motion was redone.Unit read 15 degrees of flexion and the surgeon was able to adjust the cutting block until the unit read 5 degrees of extension.After cut was made the surgeon noticed that the cut "didnt look right" an im guide was used to redo the cut.Item worked normally on the tibia and the case was completed with no other issues.The femoral registration was started with the leg in flexion.This was the only position the allowed the unit to show the green box.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: ORTHALIGN PLUS NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12099233
• Report Number: 3007521480-2021-00015
• Device Sequence Number: 3529624
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 403001-05
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention