ARTHREX

Additional Manufacturer Narrative

NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE DEVICE AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING THE COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT HDS LONG OPERATIVE LEG SPAR WILL NOT REMAIN WHEN FORCE IS APPLIED. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.