ULTRAPOWER BUR, ROUND DIAMOND (MUSTARD), 2.0MM
Received Jan 19, 2010 · Event occurred Jan 5, 2010
Report 1017294-2010-00003 · MDR key 1584604
Device
Generic name
Instrument, Surg, Orthopedic, Pneumatic
Manufacturer
Conmed LinvatecCatalog number
00702126200
Lot number
BBD23121
Product problems
- Detachment Of Device Component
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
OUR (B) (4) DISTRIBUTOR REPORTED THAT DURING RECEIVING AND INSPECTION OF THIS DEVICE, THEY FOUND THE BUR LOOSE FROM THE CLAMSHELL INSIDE THE STERILE PACKAGING. THERE WAS NO REPORT OF COMPROMISE TO THE STERILITY OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THIS BUR AND PACKAGING WAS RECEIVED FOR EVALUATION. 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 WHICH AFFECTED THE STERILITY OF THE DEVICE. 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.