MalfunctionKFK
LARGE BONE, HALL BLADE, OSCILLATING
Received Apr 5, 2010 · Event occurred Dec 11, 2009
Report 1017294-2010-00048 · MDR key 1656703
Device
Generic name
Blade, Saw, General & Plastic Surgery
Manufacturer
Conmed LinvatecCatalog number
00507112900
Lot number
100134
Product problems
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
OUR (B)(4) DISTRIBUTOR REPORTED FINDING A DEFECT IN THE PACKAGE CONTAINING THIS STERILE BLADE. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THIS BLADE AND PACKAGING WAS RECEIVED FOR EVALUATION. A VISUAL EXAMINATION CONFIRMED A HOLE IN THE PACKAGE WITH POTENTIAL BREACH IN PRODUCT STERILITY. THE CAUSE OF THIS FAILURE COULD NOT BE DETERMINED.