MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM

Model Number	02.07.0414PSF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 march 2020: lot 1900591: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional item involved in the event, batch review performed on 10 march 2020: gmk-revision 02.07.10.4563 torque limiter wrench - 6nm lot 1752438: lot 1752438: (b)(4) items manufactured and released on 05-jan-2018.No anomalies found related to the problem.To date no any similar event reported.
Event or Problem Description
During final implantation of a revision knee surgery, the tibial insert screw had broken of while the surgeon was attempting to put the poly on with the torque limiting driver.As a result, the threaded portion of the insert screw was stuck and could not be removed from the baseplate.The surgeon had to remove the poly and the agent had to provide another poly (uc poly) to complete the case.There was a 10 minute delay in the case and the surgery was completed successfully.The screwdriver used is not correct because has a tourquelimiter of 6 nm instead of the correct one that has a tourquelimiter of 3.5 nm.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9882641
• Report Number: 3005180920-2020-00192
• Device Sequence Number: 2794047
• Product Code: JWH
• UDI-Device Identifier: 07630030817847
• UDI-Public: 07630030817847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 05/08/2024
• Device Model Number: 02.07.0414PSF
• Device Catalogue Number: 02.07.0414PSF
• Device Lot Number: 1900591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/26/2020
• 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: Other
• Patient Age: 72 YR