UNKNOWN BURR DEVICE
Received May 17, 2016 · Event occurred May 9, 2016
Report 1045834-2016-11738 · MDR key 5661305
Device
Product problems
- Overheating of Device
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL NARRATIVE: BRAND NAME, COMMON DEVICE NAME, MODEL AND LOT #, PMA#, DEVICE MANUFACTURE DATE: THE PRODUCT CODE WAS UNKNOWN FOR THE BURR DEVICE. THEREFORE, THE BRAND NAME, COMMON DEVICE NAME, CATALOG NUMBER AND 510K CLASSIFICATION ARE UNKNOWN. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
THIS IS REPORT 3 OF 3 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SPINE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR DEVICE AND ATTACHMENT DEVICE WERE SMOKING AND RUNNING HOT WHEN USED TOGETHER WITH THE BURR DEVICE. THERE WAS A TWO TO FIVE MINUTES DELAY TO THE SURGICAL PROCEDURE TO OBTAIN SPARE DEVICES. THE REPORTER STATED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.