FDA Adverse Event Malfunction Summary report: N

MICROCHOICE ELITE HIGH SPEED DRILL

MDR report key: 1060997 · Received June 12, 2008

Report

Report Number: 1017294-2008-00241
Event Type: Malfunction
Date Received: June 12, 2008
Date of Event: May 23, 2008
Report Date: May 23, 2008
Manufacturer: CONMED LINVATEC
Product Code: DZI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED THIS HANDPIECE FOR EVAL AND CONFIRMED OVERHEATING. DURING TESTING THIS HANDPIECE, IT FAILED TO PERFORM TO SPECIFICATION RELATED TO MULTIPLE WORN PARTS. A REVIEW OF REPAIR HISTORY FOR THIS UNIT FOUND IT OVERDUE FOR PREVENTIVE MAINTENANCE; LAST REPAIR (B) (4) 2006. THE CUSTOMER WILL BE CONTACTED REGARDING THESE FINDINGS. ASSOCIATED REPORT: 1017294-2008-00240. THE HANDPIECE INSTRUCTION MANUAL WARNS THE USER OF THE FOLLOWING: OVERHEATING MIGHT OCCUR IF THE HANDPIECE OR ACCESSORY BEARINGS ARE WORN OR ARE NOT KEPT CLEAN. CONTINUALLY CHECK ALL PARTS OF THE HANDPIECE AND ATTACHMENTS FOR OVERHEATING. DISCONTINUE USE AND RETURN THE EQUIPMENT FOR SERVICE AS NECESSARY. OVERHEATING CAN CAUSE SERIOUS INJURY TO THE PT OR OPERATING ROOM PERSONNEL. THE USER MANUAL ALSO INFORMS THE USER THAT THE SERVICE INTERVAL FOR THIS DEVICE IS EVERY 6 MONTHS.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT DURING USE OF THIS DRILL, IT GOT HOT. THE USER FELT THE HEAT IN THE HANDPIECE AND DISCONTINUED USE. ANOTHER DRILL WAS USED TO COMPETE THE SURGERY WITHOUT INJURY OR DELAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MICROCHOICE ELITE HIGH SPEED DRILL	DRILL	DZI	CONMED LINVATEC	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			CATALOG#: 00502006000\| MICROCHOICE BUR GUARD\| LOT#: JUL07S