MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM

Model Number	02.07.0210PSF
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 11 march 2020: lot 1902787: (b)(4) items manufactured and released on 6-jun-2019.Expiration date: 2024-05-21.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
Inlay fixation screw breakage during primary surgery, the screw body remained in the tibial tray.The torque-limiter screwdriver used was the correct one.Inlay ps substituted with uc that not need the screw.
Additional Manufacturer Narrative
Visual inspection performed on the (b)(6) 2020.Visual inspection of the pictures sent of the gmk ps inlay and its secure screw.Looking at the pictures, we can confirm that the screw is broken in correspondence of its threaded shaft.The other part of the screw remained in the tibial baseplate.The tibial insert doesn't present any anomalies that could have played a role in the event.Looking at those pictures and with the information at our disposal, we can't identify a possible root cause for the event.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 2/10MM
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9887601
• Report Number: 3005180920-2020-00194
• Device Sequence Number: 2177348
• Product Code: JWH
• UDI-Device Identifier: 07630030816482
• UDI-Public: 07630030816482
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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?: No
• Operator of Device: No Information
• Device Expiration Date: 05/21/2024
• Device Model Number: 02.07.0210PSF
• Device Catalogue Number: 02.07.0210PSF
• Device Lot Number: 1902787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 07/17/2020
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 60