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

Model Number	403189
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pin driver broke during surgery when trying to remove one of the tibila resector pins.The pin was able to be removed with a pair of pliers.There was no harm to patient.
Additional Manufacturer Narrative
The device has been returned to orthalign for evaluation by an orthalign engineer, but at this time the investigation has not been completed.Once the investigation is completed a followup report will be filed detailing the conclusion on the investigation, including root cause.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.
Additional Manufacturer Narrative
The device has been returned ot orthalign for evaluation by an orthalign engineer and the investigation has been completed.The complaint was confirmed and the root cause was determined to be possible excessive force or the device being dropped, the device contributed to the reported event but surgical procedure and patient were not impacted.
Event or Problem Description
The pin driver broke during surgery when trying to remove one of the tibia resector pins.The pin was able to be removed with a pair of pliers.There was no harm to patient.

• Brand Name: KNEEALIGN 2
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 20677423
• Report Number: 3007521480-2024-00019
• Device Sequence Number: 18241470
• Product Code: OLO
• UDI-Device Identifier: 00858704006435
• UDI-Public: 00858704006435
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 403189
• Device Catalogue Number: 403189
• Device Lot Number: 19031401LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/18/2024
• 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