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

Model Number	02.07.0310PSF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 june 2021: lot 2002996: (b)(4) items manufactured and released on 29-july-2020.Expiration date: 2025-07-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
During tka, the insert locking screw broke in 2 parts.One part was in the liner pe and the other part in the tibial baseplate.The surgeon removed all the parts of tibial components (liner, tibial baseplate, and extension stem) and replaced them with same size.A 6 nm revision screwdriver has been used.
Additional Manufacturer Narrative
Information that the device was available was received on 03-august-2021 (previously it was reported that the item was not available).Device received on 09-august-2021 and analyzed on (b)(6) 2021.Visual inspection performed by r&d project manager.Intra-op breakage of the screw that secures the liner on the tibia baseplate.The screw broke in 2 parts.One remained inside the tibial tray already cemented on the bone with no possibility to be removed.For that reason, the surgeon had to replace all the tibial hardware and replace it with a new one.Also the femoral component was replaced with a new one.The screw broke because the surgeon used the wrong screwdriver to tighten it on the baseplate.The correct screwdriver to be used has a tightening torque limited at 3,5nm.It is the only screwdriver available for primary surgery.The used screwdriver has a limit tightening torque at 6nm and is usually available for revision surgery (used to secure longer stems on the components).It is not known the reason why this screwdriver was available for a primary procedure.The event is not related to a faulty device.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12107465
• Report Number: 3005180920-2021-00533
• Device Sequence Number: 14579928
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 07/13/2025
• Device Model Number: 02.07.0310PSF
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 2002996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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: 74 YR
• Patient Weight: 85