AHTB ACTIVE HEEL TRACTION BOOT

Description of Event or Problem

IT WAS REPORTED THE ACTIVE HEEL TRACTION BOOT WAS NOT HOLDING TIGHT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

H3,H6: THE DEVICE, WHICH WAS NOT USED IN A PROCEDURE, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. A VISUAL ASSESSMENT WAS PERFORMED AND SHOWED THE TWO O-RING THAT HOLD THE HEAL PAD WERE MISSING. THIS DAMAGE IS CAUSED BY WEAR FROM USE. 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 NO OTHER RELATED FAILURES. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED.