OSTEO-SITE BONE BIOPSY NEEDLE
Received Oct 16, 2013 · Event occurred Aug 23, 2013
Report 1820334-2013-00415 · MDR key 3435576
Device
Product problems
- Tip breakage
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE DEVICE WAS USED FOR BONE BIOPSY. WHEN THE PHYSICIAN TURNED THE CANNULA AFTER ADVANCING IT TO THE LUMBAR VERTEBRA, TIP OF THE CANNULA GOT DAMAGED AND SEPARATED. THEN, ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. SIMPLE X-RAY TEST AND CT CONFIRMED THAT THERE WAS NO SECTION OF THE CANNULA REMAINED IN THE PT BODY. THE SEPARATED SECTION WAS ELIMINATED FROM THE BODY IN SOME UNK WAY DURING THE PROCEDURE. THE PT HAS A FAVORABLE OUTCOME.
Additional Manufacturer Narrative
(B)(4). EACH DEVICE IS INSPECTED TO VERIFY THAT THE PRODUCT MATCHES THE WORK ORDER, SPECIFICATIONS, AND PRODUCT LABEL. ALL DEVICES ARE EXAMINED TO ENSURE THAT THE CORRECT BEVELS ARE ON THE STYLETS AND PROPER ALIGNMENT BETWEEN CANNULA AND STYLET. AN EXAMINATION OF THE RETURNED PRODUCT CONFIRMS ONE OF THE TIPS ON THE CANNULA IS MISSING. IT IS FEASIBLE TO SUGGEST THE TIP CAME OFF DUE TO BEING TURNED WHILE EMBEDDED WITH THE BONE. ROOT CAUSE IS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. PER QERA, ADDITIONAL ACTION IS NOT REQUIRED AT THIS TIME BASED ON THE ASSOCIATED RISK.