MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA KNEE INSTRUMENTS; KNEE TRIAL OFFSET

Model Number	02.07.10.8652
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 october 2024 lot 2259675: (b)(4) items manufactured and released on 05-apr-2023.No anomalies found related to the problem.To date, 5 similar events have been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager from the event description and pictures, it is clear that the anti-rotational 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.
Event or Problem Description
To prepare the tibia, the previously determined stem was connected to the keel chisel with the equally determined offset and impacted using the sliding hammer.The slide hammer was also used for removal.After two hits, the keel chisel detached from the offset adapter, but the thread in the offset adapter came loose so that the offset adapter with stem remained in the bone.Various extraction instruments from the clinic were used to remove the trial implant, unfortunately with no success, so the entire bone around the offset connector had to be carefully removed with a chisel to pick it up.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the performed analysis confirmed that 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 new modification request has been opened and managed to improve the locking system between the two components of the trial offset.Additional improvement has 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.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: KNEE TRIAL OFFSET
• 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: 20630405
• Report Number: 3005180920-2024-00916
• Device Sequence Number: 7411470
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 02.07.10.8652
• Device Lot Number: 2259675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown