MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS SHOE; SHOE FOR AMIS HIP SURGERY

Catalog Number	01.15.10.0315
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Fibula fracture detected 5 days after amis surgery.No additional surgery planned.The surgeon reports that the fracture happened while the patient's foot was in the amis shoe.
Additional Manufacturer Narrative
Batch review performed on 17 september 2024.Lot 2352015: (b)(4) items manufactured and released on 27-june-2024.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.The amis shoe is complaint and works properly; it is not possible to find the cause of the event, but it is unlikely that the event was due to the device.

• Brand Name: AMIS SHOE
• Common Device Name: SHOE FOR AMIS HIP 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: 20244206
• Report Number: 3005180920-2024-00745
• Device Sequence Number: 20684504
• Product Code: FWX
• UDI-Device Identifier: 07630040736206
• UDI-Public: 07630040736206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 01.15.10.0315
• Device Lot Number: 2352015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian