MalfunctionHTT
ULTRAPOWER BUR, ROUND, 1.0MM
Received Nov 16, 2009 · Event occurred Oct 20, 2009
Report 1017294-2009-00183 · MDR key 1541653
Device
Generic name
Instrument, Surg, Orthopedic, Pneumatic
Manufacturer
Conmed LinvatecCatalog number
00702122200
Lot number
BBD02660
Product problems
- Detachment Of Device Component
- Delivered as Unsterile Product
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 CAME LOOSE FROM THE INNER TRAY INSIDE THE STERILE PACKAGE AND COMPROMISED STERILITY. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
TO DATE, CONMED LINVATEC HAS NOT RECEIVED THIS DEVICE FOR EVALUATION. A F/U REPORT WILL BE SENT UPON RECEIPT/COMPLETION OF THE INVESTIGATION.