TC TENOTOMY SCISSDELCVD1/SERR130MM

Additional Manufacturer Narrative

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

Description of Event or Problem

COUNTRY OF COMPLAINT: USA. TIPS OF TENOTOMY SCISSOR BROKE OFF & HINGE BROKE. SCISSOR BROKE WHILE SURGEON WAS USING IT. IT ENDED UP IN 4 PIECES. X-RAY WAS NEGATIVE, ALL PIECES ARE ACCOUNTED FOR. TYPE OF SURGERY UNKNOWN AT THIS TIME, ENQUIRY HAS BEEN MADE. NO PATIENT HARM REPORTED. NO SURGICAL DELAY REPORTED.

Additional Manufacturer Narrative

INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. 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 RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. RATIONAL: THE CORROSION ON THE SCISSORS IS A SO-CALLED "STRESS CORROSION", CAUSED IN COMBINATION WITH A MECHANICAL TENSION. THIS TYPE OF CORROSION OFTEN AFFECTS AREA OR COMPONENTS THAT HAVE BEEN SUBJECTED TO HIGH TENSILE STRESS. THIS CAN BE DUE TO DESIGN LIMITATIONS SUCH AS SCREW CONNECTIONS. REPROCESSING OF THE INSTRUMENT IN A STATE OF HIGH TENSION (FOR EXAMPLE, CLOSED BLADES DURING REPROCESSING) CAN SPEED UP THE DEFECT. NO CAPA IS NECESSARY.