KERRISON DET130 DEG UP 1MM 180MMTHP
Received Aug 11, 2016 · Event occurred Jul 5, 2016
Report 2916714-2016-00706 · MDR key 5870426
Device
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 MAD 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. THE MAIN PART OF THE BONE PUNCH SHOWS VISIBLE DAMAGE TOO. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER AND FOUND TO BE ACCORDING TO SPECIFICATION, VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USER 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. WE ASSUME A MECHANICAL OVERLOAD SITUATION AS THE CAUSAL FACTOR. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
(B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018.
Description of Event or Problem
COUNTRY OF COMPLAINT: AUSTRALIA. IT WAS REPORTED THAT THE FOOTPLATE OF A KERRISON BONE PUNCH BROKE OFF DURING SURGERY, AT THE END OF THE OPERATION. THE WOUND WAS ALREADY CLOSED. X-RAY WAS PERFORMED AND FOUND TO BE NEGATIVE FOR A RETAINED PIECE.