MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT PS FIX S.3 / 12 MM

Model Number	02.07.0312PSF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The screw of the posterior-stabilized insert fractured during tightening with the torque limiter (reported use of a 3.5 nm torque limiter).The screw head detached, while the remaining fragment stayed inside the insert.The procedure was completed without removing the retained portion.
Additional Manufacturer Narrative
Batch review performed on 20 march 2026.Lot 2514843: (b)(4) items manufactured and released on 09-sep-2025.Expiration date: 17-aug-2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Considering the seminished lot of the screw only: fixing screw for ps fixing tibial insert lot.2427983: 1000 pieces manufactured on 03-jan-2025.At least 600 inserts with this screw lot have been already sold and no similar issue has been reported.Preliminary investigation performed by r&d project manager based on the provided picture.A picture of a broken screw was provided for assessment.Based on the image alone, it is not possible to determine the cause of the failure or draw any technical conclusions.A more detailed evaluation can be conducted once the physical part is returned for inspection.
Additional Manufacturer Narrative
Fu1: - device not available - investigation modified investigation performed by r&d project manager based on the provided picture: based on the information available, including the photographic evidence provided, the screw seems broken right at the beginning of the threaded section.The reported event appears to be an isolated and rare occurrence.It has been confirmed that other screws from the same manufacturing lot have been successfully implanted without any reported issues, supporting the absence of a systematic product-related concern.Although it has been confirmed that the proper torque limiter was used during the procedure, other contributing factors may have played a role in the screw breakage, including possible suboptimal alignment between the screw and the threaded hole during insertion.Such conditions may generate localized stress on the component during screwing.As the affected components will not be available for further inspection or laboratory analysis, it is not possible to determine or conclusively confirm the exact root cause of the event based on the currently available evidence.- conclusion based on the information available, no definitive root cause can be established.Case-specific application factors, such as possible suboptimal alignment during screw insertion, may have contributed to the reported screw breakage, but no confirmation can be made for this case.The device history record review does not indicate any potentially related manufacturing issue.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT PS FIX S.3 / 12 MM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 24762680
• Report Number: 3005180920-2026-00277
• Device Sequence Number: 21401758
• Product Code: JWH
• UDI-Device Identifier: 07630030817168
• UDI-Public: 07630030817168
• 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): 05/21/2026

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: 02.07.0312PSF
• Device Lot Number: 2514843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2025
• 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 Age: 46 YR
• Patient Sex: Female