AHTB ACTIVE HEEL TRACTION BOOT

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 DHR REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. A COMPLAINT HISTORY REVIEW FOUND NO OTHER RELATED FAILURES. FACTORS THAT ARE KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT/FAILURE MAY BE SHIPPING DAMAGE, COMPONENT FAILURE, OR HANDLING. 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.

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

IT WAS REPORTED THAT DURING ARTHROSCOPY, WHILE TIGHTENING THE ORANGE STRAPS ON THE ACTIVE HEEL TRACTION BOOT THE BOLT/WASHER THAT HOLDS THESE STRAPS IN PLACE SNAPPED AND BROKE AWAY FROM THE BOOT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW WAS THE PROCEDURE COMPLETED. 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.