MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS 01.15.10.0321 AMIS SOCK SINGLE USE; INSTRUMENT FOR HIP SURGERY

Model Number	01.15.10.0321
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other devices involved: batch review performed on 23-nov-2021.Amis 01.15.10.0315 amis shoe 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.
Event or Problem Description
A fibula 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.

• Brand Name: AMIS 01.15.10.0321 AMIS SOCK SINGLE USE
• 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: 12874314
• Report Number: 3005180920-2021-00936
• Device Sequence Number: 14541202
• Product Code: LXH
• UDI-Device Identifier: 07630040728027
• UDI-Public: 07630040728027
• 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): 11/25/2021

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: 01.15.10.0321
• Device Catalogue Number: 01.15.10.0321
• 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: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown