MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; MICROBLOCK ASSEMBLY

Model Number	402042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation of the femoral cutting block, distal paddle, and microblock was performed.The cutting block was able to be assembled to the returned microblock without any issue.There were no issues observed during a fit check of all three mechanical instruments.No issues were observed with the distal paddle.No issues were observed with the microblock.No issues were observed with the femoral cutting block.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.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.
Event or Problem Description
It was reported that total knee arthroplasty was performed with kneealign.Femoral distal cut was supposed to be 9mm but the femoral bone was actually cut about 15mm.

• Brand Name: KNEEALIGN 2
• Common Device Name: MICROBLOCK ASSEMBLY
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12099232
• Report Number: 3007521480-2021-00014
• Device Sequence Number: 14450387
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• 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
• Report Date (Section B): 06/29/2021

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: 402042
• Device Catalogue Number: 402042
• Device Lot Number: 12050101Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 07/01/2021
• 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