MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.10.8652 TRIAL OFFSET 5MM; HIP TRIAL OFFSET 5MM

Catalog Number	02.07.10.8652
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 15 january 2024.Lot 2158375a: (b)(4) manufactured and released on 28-feb-2022.No anomalies found related to the problem.To date, another similar event has been reported on the same lot.
Event or Problem Description
The anti-rotational insert of the trial offset broke.The offset trial and the stem were blocked in the intramedullary canal.The broken part was removed and the surgery was completed successfully despite 30 minutedelay.
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.A new modification request has been opened and managed to improve the locking system between the two components of the trial offset.Correction: h.5 is no, the device is not labeled for single use.

• Brand Name: GMK-REVISION 02.07.10.8652 TRIAL OFFSET 5MM
• Common Device Name: HIP TRIAL OFFSET 5MM
• 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: 18674302
• Report Number: 3005180920-2024-00020
• Device Sequence Number: 6144281
• 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): 03/22/2024

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: 2158375A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female