MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TRIAL OFFSET 3MM; INSTRUMENT FOR KNEE SURGERIES

Catalog 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	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On removal of the trial assembly components, from the tibia bone, the anti-rotational insert of the trial offset came out.The trial stem remained in the tibial.It was removed easily with a kocher.No delay in the surgery due to this event.
Additional Manufacturer Narrative
Batch review performed on 23 october 2023: lot 2259674: 33 items manufactured and released on 24-mar-2023.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.Preliminary investigation: 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 was unable to withstand the blows and disengaged from the offset body itself.

• Brand Name: GMK-REVISION TRIAL OFFSET 3MM
• Common Device Name: INSTRUMENT FOR KNEE SURGERIES
• 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: 18184208
• Report Number: 3005180920-2023-00878
• Device Sequence Number: 20754833
• Product Code: LXH
• UDI-Device Identifier: 07630345713148
• UDI-Public: 07630345713148
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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 Catalogue Number: 02.07.10.8651
• Device Lot Number: 2259674
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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: Male
• Patient Race: White