MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; THREADED PIN

Model Number	402395
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An orthalign distributor reported that when removing a short pin it broke.With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result with pins breaking.The pin in this case was removed and no patient injury was caused by this instrument malfunction.No product return is expected as orthalign was informed it was discarded post-surgery thus the initial report cannot be confirmed.Without the product orthalign was unable to perform a device history record review or a failure anaylsis.No further information was made available to orthalign and the investigation has been closed.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.
Event or Problem Description
It was reported that total knee arthroplasty was performed with kneealign on(b)(6) 2022.When removing a short pin on femoral side, the pin broke.The broken pin was removed from the patient body.No adverse event occurred.

• Brand Name: KNEEALIGN 2
• Common Device Name: THREADED PIN
• 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: 13758057
• Report Number: 3007521480-2022-00001
• Device Sequence Number: 20326908
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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: 402395
• Device Catalogue Number: 402395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown