MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN; SURGICAL NAIGATION SYSTEM

Model Number	401587
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	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported the resection stylus measured "incorrectly" and that the device may be "flexed when inserted into the cutting block.
Additional Manufacturer Narrative
Orthalign has requested the device be returned for evaluation.If the device is returned an investigation will be completed to confirm the complaint and identify the root cause of the incident will be completed.A followup report will be sent to report the findings of the investigation once it has concluded.

• Brand Name: KNEEALIGN
• Common Device Name: SURGICAL NAIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo 92646
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso viejo, CA 92646
• MDR Report Key: 17577733
• Report Number: 3007521480-2023-00012
• Device Sequence Number: 21084256
• Product Code: OLO
• UDI-Device Identifier: 00858704006237
• UDI-Public: 00858704006237
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: 401587
• Device Catalogue Number: 401587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown