MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE NEXTAR TIBIAL DISTAL CUTTING BLOCK EFFICIENCY; MYKNEE NEXTAR TIBIA DISTAL CUTTING BLOCK - CT - GMK - RIGHT MEDIAL - SIZE 2

Model Number	15.1242
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 28 march 2025.Lot: 195373k: (b)(4) items manufactured and released on 19-jul-2024.Expiration date: 2025-02-10.No anomalies found related to the problem.The other lot involved is: lot: 210276k: (b)(4) items manufactured and released on 30-jan-2025.Expiration date: 2025-08-13.No anomalies found related to the problem.Clinical evaluation performed by medical affairs director.Due to an error in logistics, the patient specific guides used to perform this total knee replacement had been designed for a different patient, with identical name but different date of birth.We cannot evaluate the exact potential risks of this event.However, the surgeon felt that the guide were not matching perfectly from the beginning, so he kept his judgement alert for the whole operation and decided that the result was satisfactory.From the xrays supplied, we cannot identify any alarming malposition.Branch investigation: during the procedure, the surgeon noticed improper fitting and sizing issues.After the surgery, a post-case review was requested, revealing that the incorrect guides had been used.The sales representative, who was not present during the procedure, confirmed the error.In the warehouse, only the incorrect guides with matching case code letters were available.The patient's date of birth and lot number were not verified.Additionally, the expired psis could not be scanned into the system.The warehouse informed the sales representative about the expired guides, who then notified the surgeon.Despite being aware of their expiration, the surgeon decided to proceed with the surgery.To address the recent incident, the branch will implement a training module and enforce strict compliance with the updated process for my solutions products, including their supply, utilization, and a tighter control process for handling expired products.The event is the result of a lack of diligence of the branch and staff present in the operating room.
Event or Problem Description
Medacta australia sent the incorrect guides s_bur_rsk_al_19021938 (195373k), which were used during the surgery, instead of s_bur_rsk_al_26091945 (210276k).All tibial and femoral cuts were performed using the incorrect psi guides.During the procedure, the surgeon noted that the guides did not fit well and that the sizing was incorrect.For this reason, after the surgery, he requested a post-case review, and the sales representative (who was not present during the surgery) discovered that the wrong guides had been used.In the australian warehouse, the only available guides with matching letters of case code were the incorrect ones.However, neither the patient's date of birth nor the lot number was checked.Additionally, since the psis were expired, the warehouse was unable to scan them into the system.The warehouse then informed the sales representative about the expired psis, who in turn notified the surgeon.Despite knowing that the guides were expired, the surgeon approved their use for the surgery.
Additional Manufacturer Narrative
On 22 may 2025, the branch informed us that the devices are not available for investigation.

• Brand Name: MYKNEE NEXTAR TIBIAL DISTAL CUTTING BLOCK EFFICIENCY
• Common Device Name: MYKNEE NEXTAR TIBIA DISTAL CUTTING BLOCK - CT - GMK - RIGHT MEDIAL - SIZE 2
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21718981
• Report Number: 3005180920-2025-00211
• Device Sequence Number: 21186921
• Product Code: JWH
• UDI-Device Identifier: 07630971271722
• UDI-Public: 07630971271722
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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 Expiration Date: 02/10/2025
• Device Model Number: 15.1242
• Device Lot Number: 195373K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 105 KG