KERRISON DETACH 130DG UP 200MM 1MM THIN

Additional Manufacturer Narrative

IF ADDITIONAL INFORMATION OR INVESTIGATION RESULTS BECOME AVAILABLE, THEY WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A KERRISON. THE TIP OF THE DEVICE BROKE DURING USE IN A C4-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AS THE PIECE WAS EASILY VISIBLE. AN X-RAY WAS NOT REQUIRED; THERE WAS LESS THAN 5 MINUTE DELAY REQUIRED TO REPLACE THE INSTRUMENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE FRAGMENT WAS NOTED TO BE EXTREMELY SMALL. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4).

Additional Manufacturer Narrative

B3, D4 AND F8 - UPDATED PRODUCT AVAILABLE FOR INVESTIGATION IN A DECONTAMINATED CONDITION. FAILURE DESCRIPTION THE KERRISON PUNCH SHOWS A BROKEN FOOTPLATE. INVESTIGATION VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE FOOTPLATE IS TOTALLY BROKEN OFF. 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 (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER WITH THIS ERROR PATTERN. EXPLANATION AND RATIONALE THE FAILURES FOUND IN OUR INVESTIGATION ARE SHOWING CLEAR SIGNS OF AN OVERLOAD SITUATION DURING THE PROCEDURE ITSELF. ESPECIALLY THE 1 MM KERRISON REQUIRE TO AVOID OVERLOAD SITUATIONS AS THEY ARE DESIGNED FOR DELICATE USE ONLY (SEE HINTS IN INSTRUCTIONS FOR USE (IFU)). WE WERE NOT ABLE TO DETECT ANY HINT FOR A MATERIAL DEFECT OR A PRODUCTION ERROR. PER IFU: WARNING - FIGURE 5 - HINTS REGARDING OVERLOAD DAMAGE TO, OR DESTRUCTION OF THE PRODUCT CAUSED BY INCORRECT HANDLING! - USE THE PRODUCT ACCORDING TO ITS INTENDED USE - AVOID OVERSTRAINING THE PRODUCT BY TURNING OR LEVERING MOVEMENTS DURING THE PUNCHING PROCEDURE (ESPECIALLY APPLIES TO KERRISON BONE PUNCHES WITH THIN FOOT PLATE) - USE KERRISON BONE PUNCHES WITH THE THIN FOOT PLATE ONLY FOR REMOVING SMALL, SOFT BONE PARTS AND SOFT TISSUE - PUNCH OUT ONLY AS MUCH TISSUE AS THE CAVITY BETWEEN THE FOOT AND SLIDER PART CAN ACCOMODATE CONCLUSION AND ROOT CAUSE DUE TO THE CURRENT DEVIATION AND ACCORDING EXPLANATION AND RATIONALE ABOVE, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE-RELATED. A CAPA IS NOT NECESSARY.

Description of Event or Problem

NO UPDATES.