KERRISON DETACH 130DG UP 200MM
Received Aug 13, 2015 · Event occurred Apr 10, 2015
Report 2916714-2015-00716 · MDR key 5011609
Device
Product problems
- Break
Patient
Not reported
- No Code Available
Narrative
Additional Manufacturer Narrative
US REPORTING AGENT NOTIFIED ON (B)(4) 2015. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). TIP BROKE FROM DEVICE DURING A SPINAL FUSION PROCEDURE. X-RAY WAS REQUIRED TO ENSURE REMOVAL OF BROKEN PIECE FROM PATIENT. MICROSCOPIC EXAMINATION ALSO PERFORMED.
Additional Manufacturer Narrative
(B)(4). MANUFACTURING SITE EVALUATION: FK961B: THE TIP IS BROKEN. THE TIP FELL IN PATIENT AND WAS RECOVERED AFTER X-RAY. THE TIP IS BROKEN. THE KERRISON PUNCH WAS ANALYZED BY MICROSCOPE AND HARDNESS TESTING WAS COMPLETED. 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 RAPTURE. THE HARDNESS TEST CONFIRMED THE PRE-SET VALUES. SET POINT: 420 +110 HV5, RESULTS: 496 HV5. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST LIKELY USER RELATED. NO ACTION IS REQUIRED.