LOVE-GRUENWALD PITUITARY FCPS,

Description of Event or Problem

CUSTOMER STATED THAT THE LOWER PORTION OF THE JAW SNAPPED OFF WHILE IN USE. ADDITIONALLY, THE ACCOUNT STATED, THE INSTRUMENT WAS BEING UTILIZED DURING A LAPAROSCOPIC DISCECTOMY WHEN THE LOWER PORTION OF THE JAW BROKE OFF INSIDE OF THE PT. THE CASE WAS DELAYED WHILE THE SURGEON LOOKED FOR THE BROKEN PIECE ON X-RAY. THE X-RAY REVEALED THE MISSING PIECE WAS IN THE PT'S DISK SPACE. THE SURGEON REMOVED THE PIECE AND FINISHED THE CASE WITHOUT FURTHER INCIDENT. THE CASE WAS ON (B)(6) 2009, THE INSTRUMENT AND BROKEN JAW WAS SENT TO RISK MANAGEMENT AND NOT REPORTED TO (B)(6) UNTIL (B)(6) 2010.

Additional Manufacturer Narrative

THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RETURNED FOR EVAL. HOWEVER, THE COMPLETE INSTRUMENT WAS NOT RECEIVED, (THE BROKEN PIECE WAS NOT RECEIVED); THE MISSING PIECE IS CRUCIAL FOR A COMPLETE AND ACCURATE ANALYSIS OF THE CONCERN. A REVIEW OF OUR DEVICE HISTORY REPORT AND COMPLAINT HISTORY TRENDING HAS BEEN INITIATED. ALTHOUGH, THE BROKEN PIECE WAS NOT RECEIVED, AN INVESTIGATION OF THE CONCERN WAS POSSIBLE. THE TOP HALF OF THE CUTTER WAS BENT IN A MANNER OTHER THAN ITS INITIAL DESIGN. EVAL OF THE INSTRUMENT INDICATED THAT THE INSTRUMENT'S JAW WAS BENT. THIS PRODUCT IS NOT DESIGNED TO BE FLEXIBLE OR MALLEABLE. THE DEVICE HISTORY RECORD AND TRENDS HAVE BEEN REVIEWED. THERE ARE NO RECORDS OF SIMILAR OR RELATED REPORTS. SINCE THE ROOT CAUSE IS NOT ASSOCIATED WITH THE DESIGN, MANUFACTURING, MATERIALS, OR CRAFTSMANSHIP OF THESE INSTRUMENTS, A CORRECTIVE ACTION WILL NOT BE INITIATED. AS A COURTESY, A COPY OF OUR DIRECTIONS FOR USE WAS SENT TO THE CUSTOMER.