KRAYENBUEHL NERVE HOOK BALL-TIP 185MM

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

(B)(6). THE CUSTOMER FOUND THAT THE WORKING END WAS BROKEN AND A FRAGMENT WAS MISSING AFTER AN OPERATION (B)(6) 2018. THE FRAGMENT COULD NOT FIND, THEREFORE, THERE IS THE POSSIBILITY OF REMAINING INSIDE PATIENT.

Additional Manufacturer Narrative

INVESTIGATION: THE INVESTIGATION WAS PERFORMED USING A KEYENCE VHX-5000 DIGITAL MICROSCOPE. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. AN INDICATOR FOR AN OVERLOAD SITUATION IS THE BENT REMAINING PART OF THE WORKING END, MOST LIKELY CAUSED BY LEVERAGE. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND BEEN 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 FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: THIS KIND OF INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY. BASED ON THE BENT WORKING END, IT IS ALMOST CERTAIN THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. NO CAPA IS NECESSARY.