KERRISON DETACH 130DG UP 200MM 1MM THIN

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: ON-GOING

Description of Event or Problem

COUNTRY OF COMPLAINT: (B)(6). DURING A CERVICAL SPINE SURGERY, THE TIP OF THE KERRISON BROKE OFF AND FELL INTO THE PATIENT. THE SURGERY WAS DELAYED BY A FEW MINUTES, NO OTHER PATIENT HAZARD. SURGERY WAS SUCCESSFULLY COMPLETED.

Additional Manufacturer Narrative

INVESTIGATION: THE KERRISON PUNCH WAS ANALYZED BY MICROSCOPE AND HARDNESS TEST WITH A VH1150 BY WILSON. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. THE PUSHER SHOWS HEAVY SIGNS OF WEAR AND TEAR. THE HARDNESS TEST CONFIRMED THE PRE-SET VALUES. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: THIS KIND OF INSTRUMENTS IS DESIGNED FOR DELICATE USE ONLY. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE, WHICH IS ALSO CONFIRMED BY THE DEFORMED PUSHER. THE VISUAL INVESTIGATION AND THE HARDNESS TEST INDICATED THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE. CORRECTIVE ACTION: ACCORDING TO SOP (B)(4) A CAPA IS NOT NECESSARY.