AHTB UNIVERSAL HIP DISTRACTOR

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING A HIP SCOPE, THE UNIVERSAL HIP DISTRACTOR WAS UNABLE TO LOCK, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE, THE LEG WAS LOCKED MANUALLY. 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.

Additional Manufacturer Narrative

H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. 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 EVALUATION OF THE DEVICE BY THE SUPPLIER DETERMINED THAT THE MAST END CAP, SETSCREWS, THE BELLOWS, BUSHING, CAM FOLLOWER ADJUSTER, BELLEVILLE WASHERS, BELLEVILLE ADJUSTER, AND THE CAM FOLLOWER NEEDED TO BE REPLACED. NO PATIENT INJURIES OR ADVERSE CONSEQUENCES WERE REPORTED. SINCE NO PATIENT INJURIES ARE BEING REPORTED NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH COMPONENT FAILURE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO THE DEVICE, AN IMPACT EVENT INCONSISTENT WITH NORMAL USE, WEAR FROM PROLONGED USE, MISUSE OR ROUGH HANDLING, OR INADEQUATE ROUTINE MAINTENANCE. 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. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.