STRYKER
Received Nov 12, 2009 · Event occurred Oct 14, 2009
Report 1542827 · MDR key 1542827
Device
Product problems
- Fluid/Blood Leak
- Defective Device
Patient
63 YR
- Chemical Exposure
Narrative
Description of Event or Problem
AFTER CUTTING THE PATIENT'S STERNUM WITH THE REGULAR STRYKER SAW, THE SURGEON NOTED THAT THERE WAS OIL IN THE PATIENT'S WOUND. THE SAW WAS PASSED OFF THE STERILE FIELD IMMEDIATELY. THE STERNUM WAS IRRIGATED WITH WARM LACTATED RINGERS SOLUTION AND ANCEF BY THE SURGEON. IT WAS FOUND THAT AFTER MAINTENANCE OF THE SAW WAS COMPLETED BY STRYKER, THE HAND PIECE WAS NOT RESEALED APPROPRIATELY TO PREVENT LUBRICATION FROM LEAKING FROM THE HAND PIECE.
Description of Event or Problem
AFTER CUTTING THE PATIENT'S STERNUM WITH THE REGULAR STRYKER SAW, THE SURGEON NOTED THAT THERE WAS OIL IN THE PATIENT'S WOUND. THE SAW WAS PASSED OFF THE STERILE FIELD IMMEDIATELY. THE STERNUM WAS IRRIGATED WITH WARM LACTATED RINGERS SOLUTION AND ANCEF BY THE SURGEON. IT WAS FOUND THAT AFTER MAINTENANCE OF THE SAW WAS COMPLETED BY STRYKER, THE HAND PIECE WAS NOT RESEALED APPROPRIATELY TO PREVENT LUBRICATION FROM LEAKING FROM THE HAND PIECE.