UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Dec 16, 2015 · Event occurred Nov 23, 2015
Report 0001811755-2015-04550 · MDR key 5301323
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A PARTIAL BLADE AND THE HANDPIECE SAW (6206000000, SN (B)(4)) SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKE. THE RETURNED PARTIAL BLADE PART NUMBER IS UNKNOWN. INVESTIGATION RESULTS INDICATE THAT EXCESSIVE PRESSURE MAY HAVE BEEN APPLIED, BUT THIS CANNOT BE CONFIRMED, THE ROOT CAUSE OF THIS EVENT IS UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED 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
AWAITING DEVICE EVALUATION. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.