KERRISON DETACH 130DG UP 200MM 1MM THIN
Received Sep 18, 2015
Report 2916714-2015-00815 · MDR key 5089226
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: EVALUATION ON GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). THE INSTRUMENT IS BRAND NEW AND THE END OF RONGUER IS BROKEN. INTRA-OPERATIVE TIP IS BROKEN OFF.
Additional Manufacturer Narrative
INVESTIGATION WAS PERFORMED, USING THE DIGITAL MICROSCOPE VHX-5000 BY KEYENCE AND THE HARDNESS TESTER VICKERS HV5, IDENT NO. (B)(4). 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 HARDNESS TEST CONFIRMED THE PRE-SET VALUES. HARDNESS TARGET : 420 +110 HV5. HARDNESS ACTUAL: 529 HV5. 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 INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. THE VISUAL INVESTIGATION AND THE HARDNESS TEST INDICATED THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE.