ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM
Received Mar 14, 2017 · Event occurred Feb 13, 2017
Report 9610612-2017-00084 · MDR key 6404439
Device
Generic name
Cervical Stabilisation
Manufacturer
Aesculap Implant SystemsModel number
FJ933TCatalog number
FJ933T
Lot number
52252964
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
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. IT IS CLEARLY EVIDENT THAT THE INNER SIDE (HEXAGON) OF THE FJ933T, ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM IS DAMAGED. TWO PETALS ARE VISUALLY BENT. THE BROKEN TIP OF THE FJ911R, ABC SELF-LOCKING ASSISTANCE STUCK IN THE LOCKING PIN OF THE ABC SCREW. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. 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 USER RELATED. RATIONAL: WE ASSUME THAT THE COMPLAINED SCREW WAS SCREWED TOO TIGHTLY INTO THE PLATE. AS A RESULT OF THIS, TWO PETALS WERE BENT INWARDS AND THEREFORE THE LOCKING MECHANISM COULD NOT BE ACTIVATED. IT IS COMMONLY BELIEVED THAT THEREUPON THE FJ911R, WAS USED. WE ASSUME FURTHERMORE THAT DURING THE USAGE OF THE FJ911R, THIS INSTRUMENT WAS BROKEN BY EXCESSIVE FORCE (BENDING FORCES IN COMBINATION WITH TORSION FORCES) 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: JAPAN. IT WAS REPORTED THAT THE SURGEON USED FOUR (4) SCREWS IN AN OPERATION AND FOUND THAT ONE OF THE SCREWS WAS NOT LOCKED. AN ASSISTANT INSTRUMENT WAS USED TO LOCK THE SCREW AND THE TIP OF THE INSTRUMENT DID NOT GO INTO THE SCREW. THE SURGEON REMOVED THE SCREW AND USED A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT INJURY TO THE PATIENT. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00120.