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	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign distributor reported that during a tka procedure a cut was performed and the cut was much larger than the surgeon intended.This caused prolonged surgical time, but at this time there is no known injury to the patient.An investigation will be performed once the unit is returned from orthalign inc.'s distributor in singapore.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 and prolonged surgical time.
Event or Problem Description
It was reported that all calibration was done and passed.Kneealign pod has registered femur offset and centre of hip rotation performed by surgeon.Surgeon adjusted final angle as varus 1 degree for femurcutting block to sit however upon removing the kneealign pod and sensor, an obvious valgus cut was shown when the surgeon double check with a resection guide prior sawing the femur.Surgeon abort the usage of kneealign in assisting for femur cuts and proceed on using conventional jig instead.Surgeon then attempt to use knee-align again for tibial cuts, same outcome as above mentioned.Surgeon decided to proceed with conventional sawing without the aid of navigation.
Additional Manufacturer Narrative
The returned navigation unit was tested with and in-house reference sensor by performing a back-table calibration, and then simulating femoral and tibial registrations several times.All tested attempts found no issues with the navigation unit.All devices, both returned in the complaint, and in-house to orthalign, were able to pair and mechanically interface to the returned navigation unit without issue.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: KNEEALIGN 2
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 11681557
• Report Number: 3007521480-2021-00005
• Device Sequence Number: 3095722
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 133631
• Device Catalogue Number: 133631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention