MAUDE Adverse Event Report: ORTHALIGN KNEEALIGN 2; SURGICAL NAVIGATION SYSTEM

Model Number	402395
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When removing the pin from the microblock the pin head fractured and it jammed in the pin driver.The surgeon had a hard time removing the pin form the patient body, but the pin was removed.
Additional Manufacturer Narrative
At this time the device has been returned to orthalign and the investigation is in progress to confirm the problem and determine the root cause.A follow up report will be filed detailing the conclusions upon completion of the investigation.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by a broken pin.
Event or Problem Description
When removing the pin fromthe microblock the pin head fractured and it jammed in the pin driver.The surgeon had a hard time removing the pin formt he patient body, but the pin was removed.
Additional Manufacturer Narrative
The broken pin and the pin driver have been returned to orthalign for evalutation.The investigation has been completed by an orthalign engineer.The complaint is confirmed.The root cause of the pin breakage was determined to be forced removal after the pin was unscrewed at an angle that caused the edge to catch in the microblock fixation hole.Orthalign will continue to monitor the compaint data and take action if necessary.No further action is required at this time.
Additional Manufacturer Narrative
The broken pin and the pin driver have been returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The complaint is confirmed.The root cause of the pin breakage was determined to be forced removal after the pin was unscrewed at an angle that caused the edge to catch in the microblock fixation hole.Orthalign will continue to monitor the complaint data and take action if necessary.No further action is required at this time.Additional information: the confirmed incident of a pin becoming lodged in a patient's bone is a known potential risk identified in the risk management file; which is mitigated by the pins and screws being made of biocompatible stainless steel and ifu instructions to inspect the instruments for wear and damaged prior to use.The devices meet specifications; as evidenced by the dhr review which found no nonconformances or process deviations during the manufacture.The device is not used to treat or diagnose but provides a guides to surgeon for which they may use to perform the surgical procedure.The orthalign plus system provides is does not treat or diagnose a condition however, it provides additional tools for the surgeon to utilize, without superseding the surgeon's medical experience and clinical judgment.The relationship, if any of the device to the reported incident or adverse event: based on the investigation results the returned broken pin contributed to the incident.

• Brand Name: KNEEALIGN 2
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN; 153 technology dr; suite 100; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology dr; suite 100; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology dr; suite 100; irvine, CA 92618
• MDR Report Key: 19392650
• Report Number: 3007521480-2024-00006
• Device Sequence Number: 17879097
• Product Code: OLO
• UDI-Device Identifier: 00851977007178
• UDI-Public: 00851977007178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 402395
• Device Catalogue Number: 402395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/24/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown