ULTRAPOWER BUR, ROUND, 1.0MM
Received Apr 23, 2009 · Event occurred Apr 2, 2009
Report 1017294-2009-00062 · MDR key 1423512
Device
Generic name
Instrument, Surg, Orthopedic, Pneumatic
Manufacturer
Conmed LinvatecModel number
NACatalog number
00702122200
Lot number
BBC41339
Product problems
- Loose or Intermittent Connection
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
FOREIGN COUNTRY'S DISTRIBUTOR REPORTED THAT DURING RECEIVING AND INSPECTING OF THIS DEVICE, THEY FOUND THE BUR CAME LOOSE FROM THE CLAMSHELL INSIDE THE STERILE PACKAGING. THERE WAS NO REPORT OF COMPROMISE TO THE STERILITY OF THE PRODUCT. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR AND PACKAGING FOR EVAL. IN 2009, A VISUAL EXAMINATION OF THE PACKAGE CONFIRMED THE REPORT OF THE BUR LOOSE FROM THE CLAMSHELL INSIDE THE STERILE PACKAGING. FURTHER INVESTIGATION FOUND SCRATCHES ON THE POUCH AND CONFIRMED A COMPROMISE TO THE STERILITY OF THE PACKAGING. CONMED LINVATEC INITIATED AND COMPLETED A CORRECTIVE AND PREVENTIVE ACTION TO ADDRESS THIS PROBLEM. A RETAINER COMPONENT WAS ADDED TO THE PACKAGING TO PREVENT THE BUR FROM COMING LOOSE INSIDE THE CLAMSHELL.