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Patient 1
PART 03.037.017-US, LOT 9485534: MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: MAY 07, 2015. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. A PHOTO INVESTIGATION WAS COMPLETED: THE IMAGES WERE REVIEWED, AND THE COMPLAINT CONDITION COULD BE CONFIRMED AS DAMAGED THREADS WERE SEEN IN THE IMAGES. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION AND A FUNCTIONAL TEST WERE NOT ABLE TO BE PERFORMED. A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, THE EXTERNAL THREADS WERE OBSERVED TO BE STRIPPED. THE INTERNAL HOLE ON THE PROXIMAL END OF THE DEVICE WAS OBSERVED TO BE DENTED AND DEFORMED AND WAS MISSING THE RED LINE MARKING. THERE WERE SCRATCHES AND NICKS ON THE DEVICE BUT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. NO FUNCTIONAL TEST WAS PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. THE DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE; THE DEVICE FAILED IN DIMENSIONAL INSPECTION DUE TO POST MANUFACTURED DEFECT. BASED ON THE DATE OF MANUFACTURE THE RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. THE EXTERNAL THREADS OF THE DEVICE RECEIVED WERE STRIPPED; HENCE, CONFIRMING THE ALLEGATION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL ROOT CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. THE MISSING EPOXY WAS INVESTIGATED AS WELL. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.