MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; 3MM TRIAL OFFSET WITH LOCKING SYSTEM

Model Number	02.07.10.8651
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The antirotational insert of the trial offset 3mm broke and remained attached the tibial puncher, while the body of the trial offset remained stuck in the tibial canal.About 45 minutes were required to remove the broken part and the surgeon had to remove part of the tibial bone to be able to grab the offset.Broken part retrieved and surgery completed successfully.Bone quality normal.
Additional Manufacturer Narrative
Batch review performed on 12 march 2026.Lot 2259674g: (b)(4) items manufactured and released on 25-jun-2025.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Visual inspection performed by r&d project manager the visual inspection confirms a breakage of the retentive system that locks the trial offset to the tibia keel puncher.The fixation ring and the locking insert became removed from the body of the trial offset, making it difficult to remove the offset itself from the tibia.Clinical evaluation performed by clinical affairs department.An intraoperative instrument offset thread breakage occurred, resulting in retention of components within the tibial canal and necessitating prolonged and more invasive retrieval maneuvers.This led to iatrogenic bone loss and reported weakening of the tibia, representing a clinically relevant adverse event.The available postoperative radiograph shows a final implant configuration with acceptable coronal alignment; however, it does not allow assessment of the reported bone loss or structural compromise due to the availability of a single projection.Further clinical and radiographic follow-up would be necessary to evaluate potential long-term consequences.Root cause: the issue was likely influenced by a combination of the inherent mechanical limitations of the design version involved and the forces applied under the specific conditions of use.

• Brand Name: KNEE INSTRUMENTS
• Common Device Name: 3MM TRIAL OFFSET WITH LOCKING SYSTEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24738824
• Report Number: 3005180920-2026-00253
• Device Sequence Number: 16057660
• Product Code: LXH
• UDI-Device Identifier: 07630345713148
• UDI-Public: 07630345713148
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 02.07.10.8651
• Device Lot Number: 2259674G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White