AHTB ACTIVE HEEL TRACTION BOOT

Additional Manufacturer Narrative

(B)(4). H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION REVEALED THE ADHESIVE BACKING OF THE FOAM INSERT HAS DETACHED FROM THE SHELL AND THE SHELL WAS CRACKED ON ONE SIDE. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE A COMPONENT FAILURE OF THE ADHESIVE STRIP. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE AN ARTHROSCOPY, THE FOAM SOLE OF THE ACTIVE HEEL TRACTION BOOT HAS COME AWAY FROM THE BACK OF THE BOAT CAUSING ISSUES WHEN SECURING THE PATIENTS FOOT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

THE DEVICE, WHICH WAS USED IN A PROCEDURE, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THERE WAS NO EVIDENCE THAT THE PRODUCT DIDN¿T MEET SPECIFICATIONS AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY REVIEW FOUND OTHER RELATED FAILURES. FACTORS THAT ARE KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT/FAILURE MAY BE AN ADHESIVE/VELCRO FAILURE. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED. OUR QUALITY DEPARTMENT WILL CONTINUE TO MONITOR FOR TRENDS.