MAUDE Adverse Event Report: ORTHALIGN, INC. REFERENCE SENSOR 4

Model Number	403087-06
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	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of the returned reference sensor s/n (b)(4) did not find any issues during simulated procedures.Additionally, no navigation unit was returned so the complaint could not be confirmed.From the complaint description, the reason for the issue seen by the user is the sensor was on the impactor during impaction.Orthalign recommends removing the sensor from the impactor prior to impact.It has been found that impacting with the sensor attached can cause damage to the sensor or result in accuracy issues.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.During cup impaction, cr2 battery was depleted so another cr2 battery was used.The surgeon tried to impact cup again after he adjusted anteversion angle but angles navigation unit showed was unusual that abduction angle was over 50 degree.Subsequently, he impacted the cup with rough indication.Ball joint of the pelvic base crest was firmly fixed.

• Brand Name: REFERENCE SENSOR 4
• Common Device Name: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12294357
• Report Number: 3007521480-2021-00022
• Device Sequence Number: 4490381
• Product Code: OLO
• UDI-Device Identifier: 00858704006589
• UDI-Public: 00858704006589
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130387
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 403087-06
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• 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