MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS LEG POSITIONER 2.0 FRAME

Model Number	01.15.10.0190
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 1755656: 1 item manufactured and released on (b)(6) 2018.No anomalies found related to the problem.To date, no other similar events have been reported during the period of review.
Event or Problem Description
During the primary hip surgery on (b)(6) 2023, when the surgeon was externally rotating the leg in the amis leg positioner, the patient had a tibial spiral fracture.The surgeon continued with the case and it was completed successfully.On (b)(6) 2023, the surgeon implanted a nail to help with the fracture.The surgery was completed successfully.The patient had not been putting any weight on this leg for 2 years.The patient is a smoker aged in late 70's with a small body/stature.Due to her immobility, she had 40 degree flexion contracture.When finishing the acetabulum, doing external rotation, her knee was so stiff and wouldn't rotate and her tibia spiral fracture happened.

• Brand Name: AMIS LEG POSITIONER 2.0 FRAME
• Common Device Name: LEG POSITIONER
• 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: 16634057
• Report Number: 3005180920-2023-00192
• Device Sequence Number: 20362826
• Product Code: LHX
• UDI-Device Identifier: 07630040735773
• UDI-Public: 07630040735773
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 03/29/2023

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 Model Number: 01.15.10.0190
• Device Catalogue Number: 01.15.10.0190
• Device Lot Number: 1755656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female