Device: MY01 Device

Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure

The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.

At device insertion, the physician will complete a feedback questionnaire, and routine assessment will be performed in compliance with the standard of care. As part of the feedback questionnaire, the physician will be asked to indicate on a sliding scale "How certain are you that the sensor is in the correction position?" [1 = uncertain] - [5 = very certain].

The scale, administered part of a Clinical Report Form (CRF) titled 'Physician Survey', measures the physicians subjective level of certainty that the device sensor was inserted correctly within a patients muscle compartment. A record of 5 should be considered a positive scenario, whereas a record of 1 should indicate a negative scenario.

At insertion of device the physician will complete a feedback questionnaire on the device, the participant will be assessed for adverse events, and routine assessment will be performed.

Routine assessments will be completed by healthcare personnel as per standard of care (the 6P's [Pain, Paraesthesia, Pallor, Paralysis, Pulselessness, Poikilothermia]), and compared against the pressure readout [mmHG] indicated by MY01's MicroElectroMechanical (MEMS) pressure sensor inserted at the afflicted location.

The patient will be monitored for adverse events during treatment, and will be reassessed during the final follow-up of the participant at the first return visit to the fracture clinic. An adverse event constitutes "Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal lab findings) in participants, users or other persons, whether or not related to the investigational device."