AHTB, ACTIVE HEEL TRACTION BOOT

Additional Manufacturer Narrative

H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE PREPARING FOR A HIP ARTHROSCOPY, THE SCREW IN THE BLACK PLASTIC OF THE ACTIVE HEEL TRACTION BOOT SNAPPED, CAUSING THE PATIENT'S FOOT TO BE UNABLE TO BE SECURED, THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA AND THE CASE POSTPONED. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

H10, H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL INSPECTION REVEALED ONE OF THE TWO ORIGINAL SCREWS HAS BEEN BROKEN OF THE DEVICE AND THE SCREW THAT BROKE WAS NOT SENT BACK WITH THE BOOT. IT IS NOTED THE RETURNED DEVICE HAS A BOLT, THREE WASHERS AND A NUT HOLDING THE DEVICE'S STRAP IN PLACE. THE FUNCTIONAL EVALUATION REVEALED THE RETURNED DEVICE FUNCTIONED AS INTENDED EVEN WITH THE REPLACED SCREW. ALL THE STRAPS WORKED AS INTENDED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE UNINTENDED EXCESSIVE FORCE TO THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.