MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE STD TIBCUTBL -CT- GMK -LM- SIZE 4 -STERILE; SPECIFIC KNEE GUIDE

Catalog Number	4.1034S
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 apr 2024: lot 182716k: (b)(4) items manufactured and released on (b)(6) 2024.No anomalies found related to the problem.Analysis performed by mysolution department: our analysis of the process found out no errors.Each step has been performed correctly.The complaint mentions a satisfactory outcome of the myknee surgery for the right side of the patient, thus we compared the two planning to find out any difference.Here below you can see what we found out: in november 2022 the right side of the patient was planned, with a tibial cut of 9.0 mm from the highest plateau, in accordance to the preferences of the surgeon in january 2023 the surgeon changed his preferences for the tibial cut in february 2024 the left side of the patient was planned, with a tibial cut of 7.0 mm from the highest plateau, in accordance with the new preferences.Clinical evaluation performed by medical affair director: during primary tka with patient-specific cutting blocks, the surgeon finds that the tibial cut is too proximal and needs to recut in order to create sufficient gap.As the final implant was made using the thinnest insert available, we do not think that the recuts caused any additional bone sacrifice and most probably the position of the tibial cutting block was not correct at the time of cutting.Although the postop xrays are not available to us, we expect no clinical consequences for this case.
Event or Problem Description
The surgeon was not happy with the tibial cut performed with the myknee cutting blocks.He already discovered it after the initial tibial cut but wanted to perform the femoral distal cut first anyway.The gap was too tight, so he decided to recut the tibia.No caliper was used.The surgeon performed 3 times the tibial recut in order to obtain the sufficient flexion gap.Delay 30/40 minutes (total surgery time about 2 hours and 30 min).

• Brand Name: MYKNEE STD TIBCUTBL -CT- GMK -LM- SIZE 4 -STERILE
• Common Device Name: SPECIFIC KNEE 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: 19094640
• Report Number: 3005180920-2024-00225
• Device Sequence Number: 7268766
• Product Code: JWH
• UDI-Device Identifier: 07630030848209
• UDI-Public: 07630030848209
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/12/2024

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: 4.1034S
• Device Lot Number: 182716K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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 Age: 78 YR
• Patient Sex: Female