MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; AMISTEM BROACH V2 SIZE 5

Model Number	01.18.10.415
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 december 2024.Lot 2260392: (b)(4) items manufactured and released on 08-may-2023.No anomalies found related to the problem.
Event or Problem Description
The amistem broach could not be re-engage to the broach handle to get the broach out from the patient.Multiple attempts for up to 30 minutes to re-engage it.
Additional Manufacturer Narrative
Visual inspection during the analysis it is evaluated that the broach has some slight scratches around holes for connection with pin of broach handles.We simulated the insertion of one broach handle and the connection is possible.Despite this evidence it is possible that the scratches could affect the connection with the handles.The lot is 2022 meaning that the broach has been probably used in some surgeries and handled not ideally.The root casue remains unknown.Information reported in this fu: - device return data.-visual inspection.

• Brand Name: HIP INSTRUMENTS
• Common Device Name: AMISTEM BROACH V2 SIZE 5
• 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: 21168799
• Report Number: 3005180920-2024-01151
• Device Sequence Number: 4251932
• Product Code: LXH
• UDI-Device Identifier: 07630040745536
• UDI-Public: 07630040745536
• 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): 03/19/2025

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: 01.18.10.415
• Device Lot Number: 2260392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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: 52 YR
• Patient Sex: Male
• Patient Race: White