MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE 02.07.10.8652 5MM TRIAL OFFSET WITH LOCKING SYSTEM; SURGICAL INSTRUMENT FOR KNEE

Catalog Number	02.07.10.8652
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a revision surgery, a broken part of the trial offset with locking system remained blocked in the puncher during the surgery.The broken part is a metal crown of the offset trial.The issue caused 30-45 min of delay in the surgery.
Additional Manufacturer Narrative
Batch review performed on 01 september 2023: lot 2259675: (b)(4) items manufactured and released on 05-apr-2023.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.Visual inspection performed by r&d manager: the visual inspection 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 (b)(4) has been opened to improve the locking system between the two components of the trial offset.Specific test to simulate the trial extraction will be performed before to release the new version.Other device involved: gmk hinge 02.07.10.3515 puncher #3/4 revision lot 1412528: (b)(4) items manufactured and released on 02-feb-2015.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.
Additional Manufacturer Narrative
Correction: h1 is malfunction.H5 is no.H5 is fracture.H8 is reuse.

• Brand Name: GMK HINGE 02.07.10.8652 5MM TRIAL OFFSET WITH LOCKING SYSTEM
• Common Device Name: SURGICAL INSTRUMENT FOR KNEE
• 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: 17798550
• Report Number: 3005180920-2023-00741
• Device Sequence Number: 5761922
• Product Code: LXH
• UDI-Device Identifier: 07630345713155
• UDI-Public: 07630345713155
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 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: 02.07.10.8652
• Device Lot Number: 2259675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/10/2023
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White