AHTB, ACTIVE HEEL TRACTION BOOT

Additional Manufacturer Narrative

H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 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. A CLINICAL REVIEW STATES THAT THE PROVIDED COMPLAINT DOCUMENT NOTED THAT THE REPORTED EVENT DID NOT CAUSE HARM, INJURY, OR IMPACT TO THE 45-YEAR-OLD MALE PATIENT. SINCE NO PATIENT INJURIES ARE BEING REPORTED NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A RIGHT HIP ARTHROSCOPY AND ACETABULAR LABRAL REPAIR, THE STRAPS OF THE ACTIVE HEEL TRACTION BOOT DID NOT WORK TO ADJUST, WITH GREATER DIFFICULTY THE STRAP THAT GOES ON THE ANKLE PART. WHEN DOING TRACTION, THE ANKLE STRAP CAME LOOSE, WHICH MADE THE SURGERY DIFFICULT AND THE DOCTOR WAS UNCOMFORTABLE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.