MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MYKNEE PPS STD FEMDISCUTBLOCK-MRI-GMK-LM-SIZE 3; PATIENT SPECIFIC SURGICAL GUIDE

Catalog Number	8.2013
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation: the planning was initially efficiency based and then was modified to metallic based as per medacta usa request.However, the surgeon and his sales agent were not informed of this modification so the surgery was performed using efficiency set.Mysolution analysis: 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
Myknee surgery was intended to be performed using metallic instrument set instead of efficiency instrument set (note: the planning were initially created with efficiency set but then changed to metallic set).However, this information did not reach the surgeon correctly, who performed the surgery using the efficiency set.The distal femoral bone was cut more than planned, and a thicker liner was used to compensate for this.

• Brand Name: MYKNEE PPS STD FEMDISCUTBLOCK-MRI-GMK-LM-SIZE 3
• Common Device Name: PATIENT SPECIFIC SURGICAL 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: 18037497
• Report Number: 3005180920-2023-00904
• Device Sequence Number: 7344783
• Product Code: JWH
• UDI-Device Identifier: 07630030897368
• UDI-Public: 07630030897368
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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 Expiration Date: 05/25/2024
• Device Catalogue Number: 8.2013
• Device Lot Number: 170591K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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: 81 YR
• Patient Sex: Female