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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/03/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 281268760
• Report Number: 3005180920-2021-00936
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630040728027
• UDI-Public: 07630040728027
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.15.10.0321
• Device Catalogue Number: 01.15.10.0321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other