CARB-BITE MAYO-HEGAR NH 6
Received Feb 24, 2010
Report 2430952-2010-00009 · MDR key 1616364
Device
Product problems
- Break
- Flaked
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER INITIALLY REPORTS THAT THE CARBIDE INSERT BROKE DURING SURGERY (CLOSING A SIGNIFICANT LACERATION) ON (B)(6) 2010. AN X-RAY FOUND PIECES OF THE INSTRUMENT IN THE PT. DEVICE IS APPROXIMATELY 10 YEARS OLD. THERE WAS NO PT INJURY. DURING A SUBSEQUENT PHONE CALL THE CLINIC MGR REPORTED THAT THE CARB-BITE INSERT "FLAKED OFF" INTO THE WOUND. AFTER FIRST X-RAY THE WOUND WAS OPENED, IRRIGATED TO REMOVE ALL INSTRUMENT PARTICLES, AND SECOND X-RAY SHOWED NO REMAINING FOREIGN BODIES IN THE WOUND.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.