MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA NEXTAR KNEE PLATFORM; NEXTAR KNEE MYKNEE NEXTAR TIBPINPOSITIONER_ASS-CT-GMK-LM

Model Number	15.8010
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 28 july 2025.Lot 224523k: 4 items manufactured and released on 10-jul-2025.Expiration date: 18-oct-2025.No anomalies found related to the problem.Patient match planning review knee the analysis of the mysolutions process found out no errors.Regarding the tibial guide, the navigation pins are positioned at the standard quote from the tibial cut.This standard quote guarantees a 4 mm distance between the most proximal navigation pin and the tibial implant as planned in the validated revision.The 4 mm distance guarantees some safety margin against the risk of impingement between the reamer and the navigation pins.Analysis performed by r&d project manager the case has been analyzed and no issues has been detected.As for other similar cases, a clearence of about 4mm has been left between the keel and the proximal pin of the pps block.It can be hypotized that a misplacement of the guide on the bone could lead to a reduction of this clearence and to a possible impingment.To avoid the possible impingent, the distance of 4mm will be increased to 7-8mm in the future cases.The planning review did not reveal any anomalies contributing to the issue, and the standard position (4 mm), which ensures no interference between the pins and the tibial implant, was confirmed.However, it is possible that the pins were suboptimally positioned during the procedure, which may have led to the impingement.
Event or Problem Description
During tka, the tibial insert trial could not be properly placed into the intended position.Upon review by the surgeon, it was determined that the cause was misalignment between the keel trial and the tibial tray trial; the keel trial was not seated correctly.Several attempts were made to impact the keel trial and insert the tibial insert trial, but the issue could not be resolved.After removing the keel trial and visually inspecting the intramedullary canal, it was found that the nextar target holder fixation pin was interfering with the keel trial.The depth of the fixation pin was manually adjusted until the interference was eliminated.The surgeyr was completed successfully.The total surgery time was 1 hour and 45 minutes, and the delay time was 30 minutes.

• Brand Name: NEXTAR KNEE PLATFORM
• Common Device Name: NEXTAR KNEE MYKNEE NEXTAR TIBPINPOSITIONER_ASS-CT-GMK-LM
• 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: 22737154
• Report Number: 3005180920-2025-00743
• Device Sequence Number: 7198564
• Product Code: JWH
• UDI-Device Identifier: 07630345731647
• UDI-Public: 07630345731647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: 10/18/2025
• Device Model Number: 15.8010
• Device Lot Number: 224523K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian