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

Model Number	403001-05
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the navigation unit.While performing the cup implantation the accuracy of the navigation unit was off by greater than 3 degrees.Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees.An investigation will be preformed once the unit is returned from orthalign inc.'s distributor in (b)(6).With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result from an accuracy malfunction of greater than 3 degrees.A follow up report will be filed with the investigation findings.
Event or Problem Description
It was reported that total hip arthroplasty was performed with hipalign in the afternoon 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.Only the abduction angles became bigger when impacted.
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.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo, ca
• MDR Report Key: 9923332
• Report Number: 3007521480-2020-00007
• Device Sequence Number: 3130790
• Product Code: OLO
• UDI-Device Identifier: 00851977007734
• UDI-Public: 00851977007734
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: 403001-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement 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