MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS MOBILE LEG POSITIONER 2.0 FRAME; HIP INSTRUMENT

Catalog Number	01.15.10.0190
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Bone fracture occurred during the external rotation of the leg with the amis leg positioner.No additional treatment was performed and the surgery was completed successfully.(b)(6) year-old patient with poor bone quality.It is unknown whether or not the surgeon will fix the fracture.
Additional Manufacturer Narrative
Batch review performed on 21 febr 2024.Lot 1213764: (b)(4) item manufactured and released on 23-jul-2014.No anomalies found related to the problem.Clinical evaluation performed by medical affairs department during pha surgery on a 96 year old patient, the tibia fractured on the distal part.According to report, the fracture occured during the external rotation of the leg with the amis leg positioner.It may be possible that due to the low bone quality of the patient and the small overall dimension of the tibia the applied tortional force resulted excessive.

• Brand Name: AMIS MOBILE LEG POSITIONER 2.0 FRAME
• Common Device Name: HIP INSTRUMENT
• 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: 18854200
• Report Number: 3005180920-2024-00102
• Device Sequence Number: 8173109
• Product Code: FWX
• UDI-Device Identifier: 07630040735773
• UDI-Public: 07630040735773
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 01.15.10.0190
• Device Lot Number: 1213764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2014
• 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 Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian