MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2 PIN DRIVER; ORTHOPEDIC SURGICAL INSTRUMENT

Model Number	403189
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that total knee arthropalsty was performed with kneealign on (b)(6) 2023.During procedure, after surgeon attached a pin to the pin driver (p/n 403189), he started drilling the pin to the patient's femoral bone.He found that the pin axis was so eccentric that it was about to damage the patient's blood vessel.
Additional Manufacturer Narrative
At this time, the device has been returned, and investigation to confirm the complaint and identify the root cause of the incident is underway.A followup report will be sent to report the findings of the investigation once it has concluded.
Additional Manufacturer Narrative
The device in question was returned to orthalign for evaluation.The investigation performed by the orthalign engineer was unable to reproduce the reported event.No device problems were identified.A full evaluation summary is attached.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: KNEEALIGN 2 PIN DRIVER
• Common Device Name: ORTHOPEDIC SURGICAL INSTRUMENT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): LUCID INNOVATIVE TECHNOLOGIES; 9244 industrial blvd ne; leland NC 28451
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 16820857
• Report Number: 3007521480-2023-00005
• Device Sequence Number: 6858578
• Product Code: OLO
• UDI-Device Identifier: 00858704006435
• UDI-Public: 00858704006435
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 403189
• Device Catalogue Number: 403189
• Device Lot Number: 18103101LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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
• Patient Sex: Unknown