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Patient 1
(B)(4). THE MOVEABLE JAW PART OF THE INSTRUMENT IS BROKEN OFF MISSING. STAINING CAN BE FOUND ALL OVER THE SURFACE OF THE INSTRUMENT. THE UNEVEN PINS ARE INDICATORS OF AN OVERLOAD SITUATION BY LEVERAGE. NO PORES, INCLUSIONS OR FOREIGN BODIES CAN BE FOUND ON THE POINT OF RUPTURE OF THE PINS. FURTHERMORE A DAMAGE OF THE BLADE CAN BE FOUND, MOST LIKELY CAUSED BY HARD TISSUE LIKE BONES. EXTRACT OF THE IFU: INTENDED USE: THE RONGEURS ARE USED FOR THE ABLATION OF SOFT TISSUE (E.G. INTERVERTEBRAL DISK TISSUE, MUCOSA, ETHMOIDAL CELLS, CELL TISSUE, NUCLEUS TISSUE, SEQUESTER MATERIAL) IN NEUROSURGERY AND SPINE SURGERY. THE RONGEURS CANNOT BE USED FOR THE ABLATION OF BONES OR ADJACENT BONE STRUCTURES, FOR WHICH PURPOSE AESCULAP RECOMMENDS USING BONE PUNCHES, BECAUSE OF THEIR HIGHER MECHANICAL LOAD CAPACITY. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. THE UNEVEN PINS AND THE DAMAGED BLADE ARE INDICATORS FOR AN OFF LABEL USAGE. ACCORDING TO THE IFU, RONGEURS CANNOT BE USED FOR THE ABLATION OF BONES OR ADJACENT BONE STRUCTURES, BUT FOR THE ABLATION OF SOFT TISSUE. A CAPA IS NOT NECESSARY.