MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE MYKNEE FEMUR DISTAL CUTTING BLOCK EFFICIENCY - CT - GMK - RIGHT

Catalog Number	6.1023SM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing process review: myknee department on the 13 july 2020.D_sca_rsk_dr_05061960 (lot.97913k).We analyzed each step of the myknee process; no errors have been found.Here below you can find the detailed analysis of the process: images qc: the dataset fully respects the protocol.The images were not expired at the time of the surgery reconstruction: the reconstructed profile follows precisely the contour of the bone, planning - landmarks: all the landmarks were taken accordingly to the process pre-op information: as per the other cases, the only information available to the my knee team was about the bones.No pre-op information was available regarding: the status of the ligaments: this information, as for all the cases, is available just to the surgeon.The thickness of the cartilage: this information is not available, since this case is ct- based.Planning proposal: in the planning proposal, all the chosen parameters are within the range of preferences set by the surgeon on the website.Planning - validation: the surgeon did not revise the planning, and the revision 0 went into automatically validation planning- choice of the size: we proposed a size 3+ for the femur and a size 3 for the tibia.We have no information regarding the sizes implanted by the surgeon.Femoral cutting block: all the pads are in contact with parts that cannot get detached.From the first image on the left we have four axial views moving distally (profile of the reconstructed bone in yellow and profile of the cutting block in green) and a 3d view: tibial cutting block: all the pads are in contact with parts that cannot get detached.Extra-analysis: no extra-analysis is possible, since we have not received any x-ray.Conclusions our analysis of the myknee process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
During myknee surgery anterior femoral notch causing a distal femur fracture post op (the same day).This fracture was reduced with a plate and balance of sphere was still perfect.

• Brand Name: MYKNEE MYKNEE FEMUR DISTAL CUTTING BLOCK EFFICIENCY - CT - GMK - RIGHT
• Common Device Name: FEMUR DISTAL CUTTING BLOCK
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10378415
• Report Number: 3005180920-2020-00491
• Device Sequence Number: 2941869
• Product Code: JWH
• UDI-Device Identifier: 07630030894756
• UDI-Public: 07630030894756
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 6.1023SM
• Device Lot Number: 97913K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 105