DIAMOND BUR, HEAVY GRIT, 5.0MM
Received Jan 24, 2008 · Event occurred Nov 8, 2007
Report 1017294-2008-00116 · MDR key 984552
Device
Product problems
- Heat
- Device, or device fragments remain in patient
- Vibration
- Metal Shedding Debris
Patient
UNK
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
THE SURGEON NOTED THAT DURING USE OF THIS BUR IN A LUMBAR VERTEBRAL PROCEDURE, IT BEGAN VIBRATING AGGRESSIVELY, THE ATTACHMENT ON THE HANDPIECE BECAME HOT AND METAL SHAVINGS FELL INTO THE SURGICAL SITE. THE SURGEON REPORTED THAT HE COULD NOT RETRIEVE ALL THE METAL SHAVINGS FROM THE SURGICAL SITE. THERE IS NO KNOWN INJURY RELATED TO THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC IS UNABLE TO COMPLETE AN INVESTIGATION BECAUSE THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. ACCORDING TO OUR DISTRIBUTOR, THE SURGEON USED THE BUR TO PLUNGE CUT. THE INSTRUCTION MANUAL FOR THIS HANDPIECE INFORMS THE USER: DO NOT USE BURS FOR PLUNGE CUTTING. DAMAGE OR INJURY MAY OCCUR. DULL BURS MAY CAUSE HEAT BUILD-UP IN THE HANDPIECE AND THE BONE. IT IS RECOMMENDED THAT SINGLE-USE BURS BE USED. THE CUSTOMER HAS BEEN ADVISED OF THIS INFO. THE OTHER REPORT NUMBERS GENERATED FOR THIS EVENT ARE: 1017294-2008-00006, 1017294-2008-00113, 1017294-2008-00114.