ACUFEX ACCESS POSITIONING SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE ACUFEX POSITIONING SYSTEM WAS NOT HOLDING INTERNAL OR EXTERNAL ROTATION. NO CASE OR PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND A MISSING BUTTON PLUG WAS OBSERVED. A FUNCTIONAL EVALUATION DID NOT REVEAL ANY PROBLEMS. THE UNIT PASSED THE ROTATION TORQUE TEST. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE ARE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW DID NOT FIND ANY RELATED FAILURES. FACTORS, UNRELATED TO THE MANUFACTURING AND DESIGN OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT, INCLUDE A FAILURE OF THE REEL TORQUE INSERT IN THE QUICK CONNECT. 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.