MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2 SYSTEM; COMPUTER ASSISTED SURGERY SYSTEM

Model Number	133631
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported a femoral resection navigated by the kneealign 2 system to be in greater than seven degrees of valgus, per visual evaluation.The actual amount of valgus was not measured.X-rays were not provided.The user reported he had some difficulty with the femoral maneuver, prior to successfully completing the step.He reported solid fixation of the instrumentation in the bone.No patient abnormalities or surgical anomalies were noted.It is unclear from the information provided what the cause of the apparent valgus resection was.The device has not been returned for evaluation.The device's manufacturing data and build records were reviewed.No issues or anomalies were discovered.Device not returned.
Event or Problem Description
The surgeon did make his cuts with the unit.He did not agree with the femoral resection (it was a excessive valgus angle) and had to revise his cut with the traditional resection tools.

• Brand Name: KNEEALIGN 2 SYSTEM
• Common Device Name: COMPUTER ASSISTED SURGERY SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbis, suite 500; aliso viejo CA 92656
• MDR Report Key: 6682593
• Report Number: 3007521480-2017-00003
• Device Sequence Number: 10809900
• Product Code: OLO
• UDI-Device Identifier: 00858704006008
• UDI-Public: (01)00858704006008(17)190331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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 Expiration Date: 02/28/2019
• Device Model Number: 133631
• Device Catalogue Number: 133631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/30/2017
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 91