MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM; KNEE TIBIAL INSERT

Model Number	02.07.0310PSF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The insert screw broke while using a wrong screwdriver.It was decided to remove the cemented tibial tray and the insert and replace them with the same range of products in order to complete the surgery.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 may 2022: lot 2116761: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-19.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 Manufacturer Narrative
The item returned for analysis on september 20th 2022.Visual inspection performed by r&d knee manager: the fixation screw of the gmk primary ps tibial insert broke in the attempt of screwing into the tibial tray.As reported in the event description, the applied torqued has exceeded the maximum torque that the screw can withstand, causing the breakage.The gmk primary surgical technique requires the use of the 3.5nm torque limiter screwdriver to achieve the optimal locking of the screw.The issue was most likely caused by the use of the wrong screwdriver during the surgery.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14591430
• Report Number: 3005180920-2022-00438
• Device Sequence Number: 2021257
• Product Code: JWH
• UDI-Device Identifier: 07630030817069
• UDI-Public: 07630030817069
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/10/2022

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 Model Number: 02.07.0310PSF
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 2116761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• 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 Sex: Unknown