KERRISON DET130 DEG UP 1MM 180MMTHP
Received Jan 27, 2017
Report 9610612-2017-00047 · MDR key 6284175
Device
Generic name
Bone Punches
Manufacturer
Aesculap AgModel number
FK906RCatalog number
FK906R
Lot number
5225875
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT THE TIP BROKE OFF THE DEVICE.
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. 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 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, AND THE BATCH HISTORY REVIEW THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE. NO CAPA IS NECESSARY.