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

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	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23-august-2024.Lot 2254377: (b)(4) items manufactured and released on 18-aug-2022.No anomalies found related to the problem.To date, 3 similar events have been reported on the same lot during the period of review.
Event or Problem Description
The anti-rotational insert of trial offset broke off and became stuck in the patient's tibia.The surgery and anesthesia were prolonged by 30 minutes, and eventually the piece was removed.The surgery was completed with no further need for the trial.
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.

• Brand Name: GMK-REVISION TRIAL OFFSET 5MM
• 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: 20085912
• Report Number: 3005180920-2024-00697
• Device Sequence Number: 7764899
• 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): 10/09/2024

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 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: 08/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White