KERRISON DET130 DEG UP 1MM 180MMTHP
Received Jan 11, 2017 · Event occurred Jan 1, 2016
Report 9610612-2017-00009 · MDR key 6243330
Device
Generic name
Micro Neurosurgical Instr. / D
Manufacturer
Aesculap AgModel number
FK906RCatalog number
FK906R
Lot number
7102
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
INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE INSTRUMENT. THE BROKEN OFF TIP IS MISSING. ADDITIONALLY WE MADE A VISUAL INSPECTION OF THE FRACTURE SURFACE. THE SLIDER OF THE BONE PUNCH SHOWS VISIBLE DAMAGE. FURTHERMORE WE MADE A VISUAL INSPECTION OF THE MAIN PART OF THE BONE PUNCH. HERE WE FOUND UNKNOWN DEPOSITS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. THIS KIND OF INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY. WE ASSUME A MECHANICAL OVERLOAD SITUATION AS THE CAUSAL FACTOR. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: AUSTRALIA. IT WAS REPORTED THAT THE TIP BROKE OFF DURING THE SURGERY.