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

Model Number	02.07.F11066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 february 2022.Lot 175534: (b)(4) items manufactured and released on 21-dec-2017.Expiration date: 2022-11-21.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.
Event or Problem Description
The extension stem screw broke during surgery.The surgeon had to remove the cemented tibial tray on the patient to change it to another cemented tibial tray, the liner was also changed.The locking screwdriver used was the torque limiter wrench of 6 nm.
Additional Manufacturer Narrative
Batch review performed on 07 february 2022.Lot 175534: (b)(4) items manufactured and released on 21-dec-2017.Expiration date: 2022-11-21.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.
Event or Problem Description
The extension stem screw broke during surgery.The surgeon had to remove the cemented tibial tray on the patient to change it to another cemented tibial tray, the liner was also changed.The locking screwdriver used was the torque limiter wrench of 6 nm.
Additional Manufacturer Narrative
Note: initially it was reported that the extension stem screw broke.Finally, it was discovered that liner screw broke during surgery.Batch review performed on 12 april 2022.Lot 2106049: (b)(4) items manufactured and released on 20-aug-2021.Expiration date: 2026-0721.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.Visual inspection performed by r&d project 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 surgeon has wrongly used the 6nm torque limiter screwdriver (ref.02.07.10.4563).The applied torqued has exceeded the maximum torque that the screw can withstand, causing the breakage.The gmk primary surgical technique prescribes to use of the 3.5nm torque limiter screwdriver (02.07.10.4577) to guarantee that the optimal locking of the screw is achieved.Based on the available information, it's possible to assert that the event has not been caused by a faulty device.
Event or Problem Description
The liner screw broke during surgery.The surgeon had to remove the cemented tibial tray on the patient to change it to another cemented tibial tray, the liner was also changed.The locking screwdriver used was the torque limiter wrench of 6 nm (ref: 02.07.10.4563).

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: KNEE TIBIAL INSERT PE
• 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: 13505001
• Report Number: 3005180920-2022-00077
• Device Sequence Number: 14790730
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2026
• Device Model Number: 02.07.F11066
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 2106049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White