MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM

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	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The antirotational insert of the trial offset 3mm broke.Broken part retrieved and surgery completed successfully.1 hour delay occurred to remove the broken part.The surgeon had to cut the diaphysis to be able to grab the offset and pull out the offset and stem.
Additional Manufacturer Narrative
Batch review performed on 4 june 2025 lot 2266127a: (b)(4) items manufactured and released on 09-oct-2023.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 the visual inspection confirms the failure of the retentive system that locks the trial offset to the tibia keel puncher.The absence of the locking elastic ring and the threaded locking insert does not allow for verification of the reason for the locking system failure.The fastening system between the trial offset and the keel puncher has been updated, passing from a system based on the fixation ring with locking insert to a monoblock system that will eliminate the risk of disassembly during the removal of the trial components from the bone.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: GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM
• 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: 22403097
• Report Number: 3005180920-2025-00592
• Device Sequence Number: 13210314
• Product Code: LXH
• UDI-Device Identifier: 07630345713148
• UDI-Public: 07630345713148
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.07.10.8651
• Device Lot Number: 2266127A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White