MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; REFERENCE SENSOR 5 HIP (RS5H)

Model Number	403087-06
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial report is being filed after the due date as the initial submission was found to have not been 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 initial report.Orthalign was able to investigate the two reference sensors.The reference sensors had the same failure analysis conclusions as listed below.Failure analysis: gyroscopes are subject to bias instabilities, meaning that the initial zero reading of the gyroscope will cause drift over time due to integration of inherent imperfections and noise within the device.To combat this effect, orthalign uses advanced filtering techniques to account for & mitigate a natural drift.If the sensor bias ends up being too large (categorized as rare & unnatural), the mitigation techniques implemented will perform poorly and ineffectively.The ineffectiveness can be observed as a "marching along" in value of the anteversion and/or abduction angles reported during cup navigation in a short period of time; how exacerbated the marching is depends on how out-of-character the biases are.The reference sensors were tested in-house by simulating cup navigation several times.An expected sensor drift of approximately one degree in either abduction or anteversion was observed during testing.This is expected as a natural phenomenon of the technology.Several cup navigations were performed but there were no issues observed during testing.The reference sensors were then autoclaved using the unwrapped instrument setting to simulate pre-procedure preparation.No leaks were observed in the housing and the simulated cup navigation testing was repeated.The repeated testing showed no issues with cup navigation after several additional attempts.Orthalign is filing this mdr with the understanding of how an inaccruate device could potentially cause harm to the patient.
Event or Problem Description
It was reported that during tha procedure, after putting one reference sensor (serial # (b)(4)) on the impactor the cup read 38 abduction and 9 degrees of anteversion then proceeded to march down to 8 degrees anteversion, 7, then 6 all the way to 3 in 15 seconds.The second reference sensor (serial # (b)(4)) read 45 degrees abduction and 25 anteversion but marched down steadily to about 20 degrees anteversion (and no movement of anything).Surgeon repeated (impactor didn't move) and same thing 45/25 except this time it marched up to 45/30.Repeated a third time and finally it was rock steady at 45/26.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: REFERENCE SENSOR 5 HIP (RS5H)
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12285141
• Report Number: 3007521480-2019-00026
• Device Sequence Number: 5098066
• Product Code: OLO
• UDI-Device Identifier: 00851977007888
• UDI-Public: 00851977007888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: 403087-06
• Device Catalogue Number: 403087-06
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1