SYSTEM 6 STERNUM BLD-30.5X1MM
Received Jun 19, 2015 · Event occurred May 27, 2015
Report 0001811755-2015-02228 · MDR key 4855734
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
6207097101
Lot number
15075026
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CONCOMITANT DEVICE ((B)(4)) IN ADDITION TO 2 BLADES FROM THE SAME LOT, WERE RETURNED FOR EVALUATION. THE 2 RETURNED BLADES MET MEASUREMENT SPECIFICATIONS. THE BLADE SUBJECT TO THIS EVENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. INVESTIGATION RESULTS OF THE HANDPIECE SAW HAD CONFIRMED THAT FULL BLADE INSERTION WAS BLOCKED BY DEBRIS IN THE DRIVETRAIN, THE DEBRIS WAS POTENTIALLY AS A RESULT OF IMPROPER CLEANING TECHNIQUES. THE IFU (INSTRUCTION FOR USE) RECOMMENDS CLEANING AND STERILIZATION PROCEDURES.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE IN A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE SEEMED TO BE 1/16 INCH LONGER THAN PREVIOUS BLADES. IT WAS ALSO REPORTED THAT IT WAS DIFFICULT TO LOCK THE BLADE INTO PLACE. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE IN A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE SEEMED TO BE 1/16 INCH LONGER THAN PREVIOUS BLADES. IT WAS ALSO REPORTED THAT IT WAS DIFFICULT TO LOCK THE BLADE INTO PLACE. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED.