KRAYENBUEHL NERVE HOOK BALL-TIP 185MM
Received Oct 12, 2017 · Event occurred Jul 13, 2017
Report 9610612-2017-00510 · MDR key 6944046
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
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. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE FO THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: DUE TO THE BENT WORKING END AND THE FRACTURE PATTERN, WE ASSUME A BREAKAGE DUE TO OVERLOAD, MOST LIKELY CAUSED BY A LEVERAGE EFFECT. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE INSTRUMENT HAS BROKEN IN THE DOG'S SPINE.