PKG. ASSY. BOOT-PAIR HIP DISTRACTOR

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: PATIENT DEVELOPED COMPARTMENT SYNDROME FROM THE BOOT PROBABLE ROOT CAUSE: PROCESS BOA LACES ROUTED INCORRECTLY USE ERRORS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT DEVELOPED COMPARTMENT SYNDROME FROM THE BOOT. SHE HAD A HIGH BMI AND WAS PLACED IN A SIZE 8 BOOT. HER CALVES WERE LARGE AND THE SETUP CREATED PRESSURE. THE LEG INVOLVED WAS THE NON TRACTION LEG.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT DEVELOPED COMPARTMENT SYNDROME FROM THE BOOT. SHE HAD A HIGH BMI AND WAS PLACED IN A SIZE 8 BOOT. HER CALVES WERE LARGE AND THE SETUP CREATED PRESSURE. THE LEG INVOLVED WAS THE NON-TRACTION LEG.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.