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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of returned navigation unit log file found a significant change in cup values were displayed after the cup was impacted.The root cause of this issue is navigating the cup with the sensor attached to the impactor while impacting.Orthalign does not recommend navigating during impaction, it can cause damage and loss of navigation accuracy.Orthalign recommends navigating, taking the sensor off the impactor, then impacting.After impaction, the "check cup" feature can be utilized to verify results.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 total hip arthroplasty was performed with hipalign in the morning with the navigation unit and reference sensor.While the surgeon was impacting cup, abduction angles was bigger and bigger such as from 60 to 70 degrees.He impacted the cup again, angles the navigation showed was proper such as 40 degree and 15 degree.The only abduction angles became bigger when impacted.

• 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: 12294353
• Report Number: 3007521480-2021-00023
• Device Sequence Number: 11884680
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• 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: 05/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1