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

Model Number	01.15.10.0315
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
An ankle bone fracture has been discovered in a patient operated with the amis leg positioner.It is unknown if the fracture happened during the surgery, it was discovered during the recovery period.The patient has now a splint to hold the fracture.
Additional Manufacturer Narrative
Batch review performed on 23-nov-2021.Lot 1951510: (b)(4) items manufactured and released on 27-may-2020.No anomalies found related to the problem.To date, another similar event has been reported on the same lot.Clinical evaluation performed by medical affairs director.Distal fibular fracture has probably occurred during tha surgery, where a leg positioner was used.The leg positioner is a manual instrument and a bone fracture, especially in elderly osteoporotic patients, is an adverse event that can occur even if no malfunction of the device occurred.

• Brand Name: AMIS SHOE
• Common Device Name: INSTRUMENT FOR HIP SURGERY
• 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: 12922535
• Report Number: 3005180920-2021-00940
• Device Sequence Number: 20273888
• Product Code: LXH
• UDI-Device Identifier: 07630040736206
• UDI-Public: 07630040736206
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/03/2021

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: 01.15.10.0315
• Device Catalogue Number: 01.15.10.0315
• Device Lot Number: 1951510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown