KERRISON DETACH 130DG UP 200MM 1MM THIN
Received Mar 17, 2017 · Event occurred Dec 14, 2016
Report 9610612-2017-00125 · MDR key 6414643
Device
Product problems
- Crack
- Crack
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION WAS PERFORMED USING A VHX-5000 DIGITAL MICROSCOPE. THE ANALYSIS OF THE FRACTURE PATTERING ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. 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 AVAILABLE LOT NUMBERS, AND FOUND TO BE VALID ACCORDING TO SPECIFICATION AT THE TIME OF PRODUCTION. ONE SIMILAR INCIDENT HAS 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 USAGE. 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 INDICATED THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE FOOTPLATE ON THE INSTRUMENT IS DAMAGED, IT APPEARS TO BE CRACKED. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: FK961B / KERRISON DETACH 130DG UP 200MM 1MM THIN. FK916B / KERRISON BLK COATED 130 UP 200X5MM REG.