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

Model Number	403087-06
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been returned and orthalign will perform an investigation into the alleged accuracy issue.Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that the patient could be subject to if the device produces inaccurate measurements.
Event or Problem Description
It was reported that after registration took place and the acetabulum was prepared, the definitive cup was loaded on the inserter.Once in position to navigate, the numbers given by this unit was off dramatically.Dr.(b)(6) was unable to use the unit as a guide due to the disparity.He also tried to use it for the leg length portion and again found the numbers to be off dramatically.No patient injury reported.
Additional Manufacturer Narrative
No fault could be found with the returned navigation unit (403001-06) s/n (b)(6).The nav.Unit passed all visual and functional tests.A review of the nav.Unit device history record (dhr) was conducted.There were no process deviations (pds) or nonconforming material reports (ncmrs) within the dhr.The device passed all manufacturing specifications prior to release.Upon investigation, the nav.Unit log indicated "reference sensor unstable" in comm check and the data received from the rs was abnormal.The rs was not returned for evaluation.During investigation, functional testing used an in-house rs and the nav unit functioned as designed.No root cause could be determined.Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.Correction to change model number from being the navigation unit (403001-06) to being the rs5h (403087-06) s/n (b)(6).

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 11382591
• Report Number: 3007521480-2021-00003
• Device Sequence Number: 19380832
• Product Code: OLO
• UDI-Device Identifier: 00810832030072
• UDI-Public: 00810832030072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 403087-06
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1