HDS TRACTION BOOT II

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT HDS TRACTION BOOT II HAD BROKEN AND BASE SNAPPED OFF. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

Additional Manufacturer Narrative

THE HIP DISTRACTOR SYSTEM IS DESIGNED TO POSITION, SUPPORT AND/OR DISTRACT THE PATIENT¿S HIP, POSTERIOR LOWER TORSO AND FOOT FOR HIP SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. BAXTER HAS CONTACTED THE ACCOUNT FOR THE DEVICE TO BE REPAIRED. THE ACCOUNT HAS DENIED SERVICE AND/OR REPAIR. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORTED EVENT WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.