MalfunctionGXJ
KERRISON DET130 DEG UP 1MM 180MMTHP
Received Jul 3, 2013 · Event occurred Apr 12, 2013
Report 2916714-2013-00073 · MDR key 3234477
Device
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
KERRISON BROKE OFF AT TIP DURING ACDF. TIP WAS FOUND IN PT. NO PT INJURY OR PROLONGING OF SURGERY.
Additional Manufacturer Narrative
EVAL: THE INSTRUMENT WAS MICROSCOPICALLY CHECKED. THE BREAKAGE AREA OF THE BROKEN FOOT PLATE FOLLOWED A PATTERN KNOWN AS "TRANSCRYSTALLINE FORCE FRACTURE". THE DIRECTION OF BREAKAGE IS TO THE RIGHT FRONT. ANY HINTS FOR A MATERIAL OR MFG ISSUE COULD NOT BE FOUND. BASED ON THE INVESTIGATION RESULTS, THIS ISSUE IS LIKELY RELATED TO HANDLING INFLUENCES.