MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TRIAL OFFSET 5MM; INSTRUMENT FOR KNEE SURGERIES

Catalog 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	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On removal of the trial assembly, the anti-rotational insert of the trial offset came out.The trial stem and trial offset remained the tibial bone.They were removed with some pliers.There were 20 minutes of delay in the surgery due to this event.
Additional Manufacturer Narrative
Batch review performed on 08 november 2023: lot 2261891: (b)(4) items manufactured and released on 09-jun-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.
Additional Manufacturer Narrative
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 information reported i nthis fu: - device returned on data 27 november 2023 -visual inspection of the device.

• Brand Name: GMK-REVISION TRIAL OFFSET 5MM
• 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: 18191306
• Report Number: 3005180920-2023-00922
• Device Sequence Number: 12572142
• Product Code: LXH
• UDI-Device Identifier: 07630345713155
• UDI-Public: 07630345713155
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/22/2023

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: 02.07.10.8652
• Device Lot Number: 2261891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: Unknown