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

Catalog Number	02.07.10.8652
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a knee revision surgery and implantation of gmk hinge system, with osteosynthesis of the tibia,the antirotational insert of the trial offset 5mm disconnected.The surgery was anyway completed successfully with a total time of 3h and a delay of 20min.It has been reported that the tibial bone of the patient was already fractured before the surgery and this fracture facilitated the removal of the piece.
Additional Manufacturer Narrative
Analysis performed by r&d project 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 (337-23) has been opened to improve the locking system between the two components of the trial offset.Batch review performed on 02-oct-2023.Lot 2254377: (b)(4) items manufactured and released on 18-aug-2022.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.
Additional Manufacturer Narrative
Device returned on 17-oct-2023.Visual inspection performed by r&d project 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.
Additional Manufacturer Narrative
Udi related data quality updates only.On 26 sep 2024, fda communicated discrepancies related to emdr reports, reviewing the discrepancies some follow-ups have been done.The correct brand name was entered (section d1) according to the gudid database.Expiration date (section d4) and implantation date (d6a) were filled in the initial report due to a human error.The involved device is a reusable instrument, does not have an expiration date and is not implantable, also, no pieces of the broken instrument have been left in the patient, therefore no implantation date should have been entered.All other details were already corrected in follow-up 1.

• 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: 17982917
• Report Number: 3005180920-2023-00815
• Device Sequence Number: 2453771
• Product Code: LXH
• UDI-Device Identifier: 07630345713155
• UDI-Public: 07630345713155
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2024

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: 08/18/2022
• Device Catalogue Number: 02.07.10.8652
• Device Lot Number: 2254377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 09/27/2023; Not provided
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/10/2023; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 90 KG