MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT PS FIXED SIZE 3/17MM; TIBIAL INSERT FIXED

Model Number	02.07.0317PSF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 august 2018.Lot 179571: 30 items manufactured and released on 01 march 2018.Expiration date: 2023-02-11.No anomalies found related to the problem.To date, 6 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The poly screw did not engage to the tibial plate.The surgeon ended up not using the screw.There was no significant delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.The initial emdr 2018-00637 has been sent august 29th 2018 with the correct fei number (b)(4) (medacta international) while the follow-up has been sent, october 24th 2018, with the incorrect fei number (b)(4).Clinical evaluation performed by medical affairs director: according to report, the safety screw meant to secure the tibial insert to the metal back did not enage and was therefore not used.This is a 17mm thick insert, so it is a case where the mechanical tests require the screw to guarantee the assembly.We cannot foresee the evolution of this situation, but the possibility of the insert dissociation exists, particularly in case of trauma or quasi-trauma.The causes of the problem do not pertain to the clinical investigation.

• Brand Name: TIBIAL INSERT PS FIXED SIZE 3/17MM
• Common Device Name: TIBIAL INSERT FIXED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7826834
• Report Number: 3005180920-2018-00637
• Device Sequence Number: 11059840
• Product Code: JWH
• UDI-Device Identifier: 07630030817380
• UDI-Public: 07630030817380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/06/2023

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: 02/11/2023
• Device Model Number: 02.07.0317PSF
• Device Catalogue Number: 02.07.0317PSF
• Device Lot Number: 179571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2018
• 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: Required Intervention
• Patient Sex: Female