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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The proximal femur fracture occurred during the surgery with the amis leg positioner upon trial reduction (internal rotation of the foot).The surgeon cabled the fracture and the surgery was completed successfully.Surgeon says it was the presence of osteophytes that could caused the fracture and half the medial calcar came off during preparation and removal of femoral bone head that greatly weakened the integrity of the proximal femur.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 1656238: 15 items manufactured and released on 08-march-2018.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.

• 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: 18018919
• Report Number: 3005180920-2023-00817
• Device Sequence Number: 7637776
• Product Code: FWX
• UDI-Device Identifier: 07630040735773
• UDI-Public: 07630040735773
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/27/2023

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: 1656238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2018
• 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: Unknown