MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM; SURGICAL INSTRUMENT FOR KNEE SURGERY

Catalog Number	02.07.10.8651
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation performed by r&d manager: from the image of the trial offset threaded insert, it looks deformed on the bottom side.The insert is fixed to the main body of the trial offset by welding on the upper part and by elastic retention system on the back side.We can immagine that the two fixation systems failed due to excessive force applied during tibia keel fixation by the fixation screw.The toothed connection allows to firmly lock the trial offset to the tibia keel and/or trial femur without the need to tight the screw with too much force.A visual inspection is necessary to better define the reason of instrument failure.
Event or Problem Description
The trial offset 3mm detached from the trial tibial baseplate during surgery.The threads inside the trial offset 3mm came out.Since no threaded part of the trial offset remained inside, 40 minutes were needed to remove the trial offset and the extension stem from the tibial canal (total surgery time of 2 ½ hours).Surgery completed successfully.
Event or Problem Description
The trial offset 3mm detached from the trial tibial baseplate (ref 02.07.10.3939 lot 2163090) during surgery.The threads inside the trial offset 3mm came out.Since no threaded part of the trial offset remained inside, 40 minutes were needed to remove the trial offset and the extension stem from the tibial canal (total surgery time of 2 ½ hours).Surgery completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6), 2023.Lot 2254376: 53 items manufactured and released on (b)(6), 2022.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Information added: - changed description of the event - added the lot number - manufacturer date - batch review.
Event or Problem Description
The trial offset 3mm detached from the trial tibial baseplate (ref: 02.07.10.3939, lot: 2163090) during surgery.The antirotational insert of the trial offset 3mm came out.Since no threaded part of the trial offset remained inside, 40 minutes were needed to remove the trial offset and the extension stem from the tibial canal (total surgery time of 2 ½ hours).Surgery completed successfully.
Additional Manufacturer Narrative
Analysis 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.A new modification request (337-23) has been opened to improve the locking system between the two components of the trial offset.Correction: event description, device not available, analysis performed by r&d project manager.
Additional Manufacturer Narrative
Additional information: device available and returned on 24 october 2023.Visual inspection performed: visual inspection confirmed the preliminary performed and conclusions of case reported also in mdr (b)(4).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.Batch review performed on 12 october 2023: lot 2257626: (b)(4) items manufactured and released on 03-jan-2023.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Corrections: lot corrected with 2257626 (correction of manufacturing date and batch).Correction of device availabily and device return date.B2 inserted other serious or important medical events.H1 inserted malfunction.H5 inserted no (labeled for single use).H6 medical device problem code - fracture.H8 inserted reuse.

• Brand Name: GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM
• 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: 17441936
• Report Number: 3005180920-2023-00630
• Device Sequence Number: 11424977
• Product Code: LXH
• UDI-Device Identifier: 07630345713148
• UDI-Public: 07630345713148
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2023

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: 02.07.10.8651
• Device Lot Number: 2257626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/10/2023; 07/10/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/01/2023; 10/04/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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: Female