AHTB UNIVERSAL HIP DISTRACTOR

Additional Manufacturer Narrative

H10 H3,H6: THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. 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. 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: (B)(4). 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 FOUND THE PLASTIC DISTRACTOR POSITIONING CONTROL BENT. A FUNCTIONAL EVALUATION FOUND THE POSITIONING CONTROL TO NOT RETURN TO THE LOCKED POSITION AS INTENDED. INSTEAD OF LOCKING WHEN THE USER NO LONGER TURNS THE HANDLE, THE HANDLE HAD TO BE TURNED INTO THE LOCKED POSITION AFTER THE HANDLE WAS USED. 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. THE COMPLAINT WAS CONFIRMED. FACTORS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT INCLUDE AN IMPACT FORCE INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, THE HANDLE OF THE "AHTB UNIVERSAL HIP DISTRACTOR" WAS BENT, SO IT DID NOT STAY IN ONE POSITION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.