MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SURGICAL MANUAL INSTRUMENT; AMIS CUP IMPACTOR TERMINAL

Model Number	01.32.10.0114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During hip surgery, the impactor terminal broke inside the cup during impaction.The breakage was not noticed and the surgeon proceeded with the positioning of the liner but the liner could not be coupled with the cup.While trying to seating the liner the surgeon noticed the broken impactor terminal inside the cup, removed it and was able to place the liner correctly.Surgery was completed successfully with 30 minutes of delay.
Additional Manufacturer Narrative
Batch review performed on 12 august 2025: lot 1212359a: (b)(4) items manufactured and released on 27-sep-2019.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager: based on the image and the details provided in the complaint description, the threaded portion of the terminal appears to be fractured in proximity to the thread relief groove.Root cause: although there could be several contributing factors, the design parameters of the version utilized may not have been fully optimized with respect to all conditions of use.
Additional Manufacturer Narrative
Vi: based on the image, the details provided in the complaint description, and the inspection of the returned device, it is clear that the threaded portion of the terminal fractured in proximity to the thread relief groove.This instrument design has since been optimized by removing the thread relief groove, thereby increasing the mechanical strength of the terminal component.The instrument involved in this complaint was manufactured prior to the implementation of this design enhancement.Fu1: device returned and visual inspection.

• Brand Name: SURGICAL MANUAL INSTRUMENT
• Common Device Name: AMIS CUP IMPACTOR TERMINAL
• 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: 22782906
• Report Number: 3005180920-2025-00779
• Device Sequence Number: 18206846
• Product Code: LXH
• UDI-Device Identifier: 07630040745314
• UDI-Public: 07630040745314
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/25/2025

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 Model Number: 01.32.10.0114
• Device Lot Number: 1212359A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 97 KG