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Patient 1
(B)(4). ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF REQUIRED. MANUFACTURING SITE EVALUATION: THE PRODUCT WAS NOT RETURNED AND PICTURES WERE NOT PROVIDED. BATCH HISTORY REVIEW: THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT. A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE: NO PRODUCT WAS AVAILABLE AND THEREFORE IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE. WE ASSUME THAT THE CAUSE OF THE FAILURE IS NOT PRODUCT RELATED. THERE IS THE POSSIBILITY THAT THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY MAINTENANCE OR USAGE RELATED. RATIONALE: UNFORTUNATELY, DUE TO THE LACK OF DATA AND WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT CAUSE. ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. DUE TO THE STATEMENT FROM QUALITY MANAGEMENT, THE INSTRUMENT CONSISTS OF THREE INDIVIDUAL PARTS. THERE IS THE POSSIBILITY FOR A LOOSENED SCREW. THIS COULD HAVE BEEN CAUSED BY IMPROPER MAINTENANCE AFTER REPROCESSING. POSSIBLY THE INSTRUMENT WAS DISMANTLED FOR REPROCESSING OR THE SCREW HAS LOOSENED FOR EXAMPLE DUE TO USAGE. ANOTHER CAUSE COULD BE THE BREAKAGE OF THE SCREW CONNECTION. THIS COULD HAVE BEEN CAUSED BY AN IMPROPER HANDLING DUE TO A MECHANICAL OVERLOAD SITUATION. IF FURTHER INVESTIGATIONS ARE REQUIRED, THE PRODUCT SHOULD BE PROVIDED FOR EXAMINATION. ACCORDING TO THE IFU, THE FOLLOWING POINTS MUST BE OBSERVED FOR SAFE HANDLING AND PREPARATION: PRIOR TO EACH USE, INSPECT THE PRODUCT FOR LOOSE, BENT, BROKEN, CRACKED, WORN, OR FRACTURED COMPONENTS; AFTER EACH COMPLETE CLEANING, DISINFECTING AND DRYING CYCLE, CHECK THAT THE INSTRUMENT IS DRY, CLEAN, OPERATIONAL, AND FREE OF DAMAGE (E.G. BROKEN INSULATION OR CORRODED, LOOSE, BENT, BROKEN, CRACKED, WORN, OR FRACTURED COMPONENTS).