OVAL BUR, EXTENDED LENGTH, (19CM)
Received Jan 18, 2008 · Event occurred Nov 29, 2007
Report 1017294-2008-00032 · MDR key 984418
Device
Product problems
- Thermal Decomposition of Device
- Melted
- Sticking
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE SUER REPORTED THAT DURING USE OF THIS SHAVER BUR IN SURGERY, THE PLASTIC HUB PART MELTED/BURNED AND THE BUR LOCKED IN THE HANDPIECE. THERE WAS NO REPORT OF PATIENT INJURY WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: TO DATE, CONMED LINVATEC IS AWAITING ADDITIONAL INFORMATION FROM THE USER FACILITY. CONMED LINVATEC RECEIVED THE DEVICE FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. DURING INVESTIGATION THE EVALUATOR FOUND THE HUB MELTED ONTO THE HIGH SPEED BUSHING. THIS TYPE OF PROBLEM CAN OCCUR IF IRRIGATION IS NOT USED DURING OPERATION OF THE DEVICE. THERE ARE NO REPORTS OF INJURY RELATED TO THIS FAILURE MODE. THE INSTRUCTION MANUAL FOR SHAVER HANDPIECES CAUTIONS THE USER: WHEN OPERATING SHAVER BLADES OR BURS THE SHAVER HANDPIECE SUCTION PROT VALVE MUST BE IN THE OPEN OR ON POSITION, AND THE SHAVER BLADE OR BUR MUST BE WITHIN THE DISTENTION FLUID OF THE JOINT. OTHERWISE, DAMAGE TO THE BLADE HUB OR BUR HUB WILL RESULT. THE USER REPORTED NOTIFICATION OF THIS EVENT TO THE AFSSAPS IN ANOTHER COUNTRY. CONMED LINVATEC WILL CONTACT THE CUSTOMER WITH ADDITIONAL INFORMATION RELATED TO THIS PRODUCT.