MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; NAVIGATION UNIT

Model Number	133631
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	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pod was not correspondence with the sensor of the kneealign.The reading on the screen was shown as 13 degree flexion, with surgeon checked on the resection guide and it's not.The issue was completed with open a new kneealign2 consumable and change of the kneealign sensor.No patient injury was reported.
Additional Manufacturer Narrative
At this time the product has not been returned for investigation.Once the product is returned from orthalign inc.'s distributor in singapore, an investigation into the alleged accuracy issue will be performed.With an abundance of caution this report is being filed with the understanding of the potential patient harm that could be caused to the patient by an inaccurate device measurement.
Additional Manufacturer Narrative
The navigation log was available for review.The first two sessions showed the ka2 was paired to rs s/n 8038 and the tka procedure was completed in each session.Upon pairing with the returned ka2 unit, the rs s/n 8038 showed a use count of 100 in the first session and 101 in the second session.In both sessions, registration was completed with the femur offset angle and resection angle found to be within tolerance.A power test of the ka2 unit was initiated by pressing the center button.The screen remained black, and the unit did not power on.The angle of flexion is measured by the reference sensor, and this data is communicated to the nav unit.It is suspected that the reference sensor s/n 0667, which was found in the navigational log, may have experienced age-related gyro bias due to its high use count.The rs was not returned for investigation.The ka2 was opened to inspect the batteries.It was observed that one battery had leaked inside the unit, as evidenced by dried battery acid on the battery and its corresponding battery clip.It cannot be determined if this battery leaked before or after the complaint event.With the batteries and the pcb no longer in acceptable condition, a procedure could not be performed on the ka2 and further investigation could not be completed.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.

• Brand Name: KNEEALIGN 2
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 14286500
• Report Number: 3007521480-2022-00003
• Device Sequence Number: 1531933
• Product Code: OLO
• UDI-Device Identifier: 00858704006008
• UDI-Public: 00858704006008
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K103829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 133631
• Device Catalogue Number: 133631
• Device Lot Number: 211109046LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown