STATLOCK CV PLUS SLIDING POST, 25 BOX

Additional Manufacturer Narrative

THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF DIFFICULTY CLOSING THE STATLOCK STABILIZATION DEVICE WAS CONFIRMED AND APPEARS TO BE RELATED TO THE CLOSING ANGLE OF THE DEVICE. THE PRODUCTS RETURNED FOR EVALUATION WERE THREE STATLOCK CV PLUS SECUREMENT DEVICES. TWO OF THE DEVICES WERE FOUND TO EXPERIENCE THE ISSUE OF DIFFICULTY CLOSING. THE THIRD SAMPLE DID NOT EXHIBIT ANY FUNCTIONAL ISSUES. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE CAUSED BY PUSHING THE SECUREMENT TAB AT AN ANGLE WHILE ATTEMPTING TO CLOSE THE DEVICE. THIS ISSUE CAN BE AVOIDED BY CENTERING THE THUMB ABOUT THE MIDDLE OF THE TAB AND PRESSING DIRECTLY DOWNWARDS. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND THE FOLLOWING OBSERVATIONS WERE MADE WHICH WERE CONSISTENT WITH THIS FAILURE TYPE: AN ATTEMPT TO TEST THE FUNCTIONALITY OF THE LOCK WAS UNSUCCESSFUL AND THE LATCHES WERE OBSERVED TO BE MISALIGNED WITH THE CATCH BASE. THE TAB HINGE EXHIBITED AN OFF-AXIS CREASE AND CONTAINED DAMAGE OUTSIDE THE HINGE CREASE. THE TAB LATCH WAS OBSERVED TO BE BENT AND HAD PLASTIC DEFORMATION WHICH WAS SEEN AT. THE POINT OF CONTACT WITH THE CATCH. THE TAB CATCH EXHIBITED PLASTIC DEFORMATION AT THE POINT OF CONTACT WITH THE LATCH. THIS FAILURE TYPE WAS RECREATED IN THE LABORATORY USING NON-COMPLAINANT SAMPLES BY CLOSING THE TAB AT AN ANGLE, OR BY PRESSING OUTSIDE THE CENTER OF THE TAB, AND THE FEATURES OBSERVED ON THE LABORATORY SAMPLES WERE SIMILAR TO THOSE ON THE RETURNED COMPLAINANT SAMPLE. THE NATURE OF THE DAMAGE OBSERVED ON THE LATCH, AND THEIR POINTS OF CONTACT ON THE CATCH BASE AS WELL AS THE CHARACTERISTICS OF THE HINGE DAMAGE, ARE EVIDENCE THAT THE DAMAGE WAS CAUSED BY MISALIGNMENT OF THE DOORS WHEN CLOSING THE DEVICE. PUSHING THE TAB AT AN ANGLE CAN CAUSE THE LATCH TO MISS THE CATCH BASE AND CAN PERMANENTLY BEND THE LATCH. AN EXAMINATION OF THE SAMPLE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. A LOT HISTORY REVIEW (LHR) OF JUEV2365 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUEV2365) HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(4).

Description of Event or Problem

IT WAS REPORTED DIFFICULT TO CLOSE/LOCK AND THE GLUE HAS ALSO BEEN POOR AND NOT ATTACHING AS NORMAL. NO OTHER INFORMATION WAS PROVIDED. TWO OF THE THREE DEVICES RETURNED FOR EVALUATIONS WERE FOUND TO HAVE THE ISSUE OF DIFFICULTY CLOSING. THIS REPORT ADDRESSES THE SECOND DEVICE.