MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY 02.07.0310PSF TIBIAL INSERT PS FIXED SIZE 3/10MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0310PSF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The screw of the ps insert broke before the torque limiter screwdriver 3.5 nm (ref 02.07.10.4577) reached the click.The surgeon removed the implant, recut to remove the cement and placed new implants.Surgery completed with 30 min delay.
Additional Manufacturer Narrative
Batch review performed on 24 april 2024 lot 2311005: (b)(4) items manufactured and released on 05-jun-2023.Expiration date: 2028-05-18.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.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager investigation based on the visual inspection of the tibia baseplate and the tibial insert sent back.The insert securing screw has been broken in two parts during surgery.The screw is broken at the beginning of its threaded part, at the upper level of the baseplate.The broken part of the screw remained into the baseplate with no possibility to be removed.As reported in the complaint description, the correct torque limiting screwdriver has been used during the surgery (ref 02.07.10.4577).Reason for screw breakage remains unknown.Malfunctioning of the screwdriver can be excluded as it was successfully used in previous and sequent surgeries.Bending stress during tightening could have been a cause for breakage.This remains an hypotetis not supported by any evidence.From visual inspection it is not possible to determine any root cause for the event.

• Brand Name: GMK-PRIMARY 02.07.0310PSF TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: KNEE TIBIAL INSERT
• 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: 19341857
• Report Number: 3005180920-2024-00320
• Device Sequence Number: 7130346
• 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): 07/03/2024

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: Health Professional
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 2311005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White