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

Model Number 402042

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 01/15/2020

Event Type  Injury  

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 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
• Type of Device: MICROBLOCK ASSEMBLY
• 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: 12099232
• MDR Text Key: 263873296
• Report Number: 3007521480-2021-00014
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention