MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MY KNEE TIBIAL CUTTING BLOCKS; MYKNEE TIBIAL CUTTING GUIDE

Model Number	4.1032
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 31 october 2024 lot 199651k: (b)(4) items manufactured and released on 25-sept-2024.Expiration date 14-04-2025 no anomalies found related to the problem.Planning review performed by mysolution department: our analysis of the process found out no errors.We reprinted the guide and the bone model, to try once again the fitting.The fitting is stable and univocal.The investigation did not reveal any anomalies in the planning or in the production and there is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
During the primary knee surgery, it was observed that the tibial cut block would not sit on the native bone properly and that the alignment was off.In detail, the cut block would not fit on the lateral side of the tibia properly.When the surgeon would try to place on the medial osteophyte it would kick the cut block forward and medial and the anterior pad would not sit flush.The bone was properly cleaned.To complete the case, the surgeon had to hold the block a certain way and pin it.There was a 25- minute delay because of the attempts to get the cut block to fit in place and the intention to use an im guide.The surgery was anyway completed successfully.A consignment set was utilized.

• Brand Name: MY KNEE TIBIAL CUTTING BLOCKS
• Common Device Name: MYKNEE TIBIAL CUTTING GUIDE
• 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: 20755832
• Report Number: 3005180920-2024-00984
• Device Sequence Number: 8561039
• Product Code: OOG
• UDI-Device Identifier: 07630030848155
• UDI-Public: 07630030848155
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 04/14/2025
• Device Model Number: 4.1032
• Device Lot Number: 199651K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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: Female