AHTB ACTIVE HEEL TRACTION BOOT

Additional Manufacturer Narrative

THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION REVEALED A BROKEN STRAP AND MISSING BUCKLE. THE PADS ARE WORN. A FUNCTIONAL EVALUATION REVEALED THE CENTER STRAPS COULD NOT BE TIGHTENED DUE TO THE BROKEN STRAP AND MISSING BUCKLE. THE COMPLAINT WAS CONFIRMED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING SET UP OF HIP ARTHROSCOPY, THE ACTIVE HEEL TRACTION BOOT WOULD NOT STAY TIGHT ON CLAMPS. THE STRAPS KEPT SLIPPING THROUGH THE CLAMPS; THEREFORE, LOST ANY TRACTION APPLIED TO THE HIP. THE STRAPS APPEARED WORN. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.