SMITH & NEPHEW, INC. DRILL,FLEXIBLE,ENDOSCOPIC,CANN, 9MM; SAW, POWERED, AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 7209738 |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/16/2014 |
Event Type
malfunction
|
Manufacturer Narrative
|
Under magnification, minimal tip flaring was noted at one spot, the tip had rolled over on the inside of the body.The break is at the laser cut at the starting hole.The shaft of the device does not appear to have any other damage, other than the break.The countersink feature is reduced to an undersized condition.The root cause was determined to be over-sharpening of the tip.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.
|
|
Event Description
|
During an acl (anterior cruciate ligament) reconstruction surgery using a drill, flexible, endoscopic, cann, 9mm the flexible drill broke right below the head of the drill bit.All of the pieces were removed from patient.No patient injury or other complications were reported.
|
|
Search Alerts/Recalls
|
|
|