MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TRIAL OFFSET 5MM; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	02.07.10.8652
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 september 2023: lot 2259675: (b)(4) manufactured and released on 05-apr-2023.No anomalies found related to the problem.To date, another similar event has been reported on the same lot during the period of review.Investigation performed in accordance with the visual inspection performed on the same device from a previous similar case: preliminary investigation in accordance with the visual inspection performed on the same device from a previous similar case, where it has been confirmed that the antirotational insert of the trial offset has been disassembled from the main body during trial removal from the bone.A new modification request has been opened to improve the locking system between the two components of the trial offset.Specific test to simulate the trial extraction were performed with positive outcomes.
Event or Problem Description
Medtronic legal received information from the attorney of the family on oct 04, 2023, medtronic received notice of a device/product legal hold notification.The reporter alleges that the use of one or more medtronic mini med 600 series insulin pumps with a damaged, missing, or broken retainer ring caused the claimant to suffer personal injuries.The allegation did not specify the pump identifier (serial number) and therefore all 600 series insulin pumps in possession of the claimant, including this pump, are considered potentially within the scope of the report pending confirmation of the affected serial number(s).When and if the affected serial number is identified, all related reports will be updated accordingly.No harm requiring medical intervention was reported.It was unknown whether the customer will continue using one of the pumps.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.The performed analysis confirmed that the antirotational insert of the trial offset has been disassembled from the main body during trial removal from the bone.During extraction of the system consisting of extension stem, trial offset and trial keel assembly from the bone, the elastic clipping of the threaded insert of the trial offset is unable to withstand the blows and disengages from the offset body itself.Additional info reported in this fu: - device returned on 4 december 2023 -visual inspection.

• Brand Name: GMK-REVISION TRIAL OFFSET 5MM
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE SURGERY
• 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: 18011677
• Report Number: 3005180920-2023-00803
• Device Sequence Number: 15300991
• Product Code: LXH
• UDI-Device Identifier: 07630345713155
• UDI-Public: 07630345713155
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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 Catalogue Number: 02.07.10.8652
• Device Lot Number: 2259675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White