MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS 01.15.10.0190 AMIS LEG POSITIONER 2.0 FRAME

Model Number	01.15.10.0190
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Spiral fracture from the center to the distal part of the tibial diaphysis during external rotation 130-150 with leg positioner.Osteosynthesis has been performed with intramedullary nails on april 20.The patient bone quality is poor.
Additional Manufacturer Narrative
Batch review performed on 13 may 2022.Lot 1213121a: (b)(4) items manufactured and released on 17-feb-2017.No anomalies found related to the problem.(no cases were reported on the original lot 1213121).

• Brand Name: AMIS 01.15.10.0190 AMIS LEG POSITIONER 2.0 FRAME
• Common Device Name: AMIS LEG POSITIONER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14426901
• Report Number: 3005180920-2022-00376
• Device Sequence Number: 17800798
• Product Code: LXH
• 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): 05/17/2022

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: 1213121A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• 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
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian