MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; GMK-REVISION 5MM TRIAL OFFSET WITH LOCKING SYSTEM

Model Number	02.07.10.8652
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary knee surgery and while the surgeon was disengaging the tibial fin punch, the 5mm trial offset with locking system broke.All broken fragments were recovered and there was no delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 june 2025 (b)(4) items manufactured and released on 09-jun-2023.No anomalies found related to the problem.To date, 1 similar event has been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager.From the analysis of the images of the complaint, the antirotational insert of the trial offset has been disassembled from the main body during trial removal from the bone.During extraction of the system consisting of extension stem, trial offset and trial keel assembly from the bone, the elastic clipping of the threaded insert of the trial offset is unable to withstand the blows and disengages from the offset body itself.A modification request has been opened and managed to improve the locking system between the two components of the trial offset.Additional improvement have been done on the design and production process in order to obtain the antirotational feature monoblock with the main body instead of two different components.
Additional Manufacturer Narrative
Additional information on the device availability: on 9 september 2025, the branch informed us that the device is no longer available.

• Brand Name: KNEE INSTRUMENTS
• Common Device Name: GMK-REVISION 5MM TRIAL OFFSET WITH LOCKING SYSTEM
• 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: 22529148
• Report Number: 3005180920-2025-00652
• Device Sequence Number: 8028789
• Product Code: LXH
• UDI-Device Identifier: 07630345713155
• UDI-Public: 07630345713155
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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 Model Number: 02.07.10.8652
• Device Lot Number: 2261891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female