MalfunctionHTW
TORNIER
Received Mar 24, 2011 · Event occurred Feb 14, 2011
Report 3004983210-2011-00001 · MDR key 2114407
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT A DRILL BIT IN USE IN SURGICAL SITE PREPARATION WAS BROKEN IN USE. A SEGMENT OF THE DRILL BIT TIP, OF UNKNOWN LENGTH, WAS PERMITTED TO REMAIN WITHIN THE BONE. NO ADVERSE IMPACT WAS REPORTED TO THE INTENDED PLACEMENT OF THE ANKLE FUSION PLATE PROSTHESIS UNDERWAY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DRILL BIT IS A CLASS I REUSABLE SURGICAL INSTRUMENT. DEVICE LOT NUMBER HAS NOT BEEN REPORTED. DEVICE RETURN FOR EVALUATION IS ANTICIPATED. THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY LEFT WITHIN THE SURGICAL SITE. (B)(4).