MalfunctionKGS
T-FIX SM INTRODUCER STRAIGHT SINGLE SUT
Received May 7, 2003 · Event occurred Mar 31, 2003
Report 1219602-2003-00071 · MDR key 459678
Device
Generic name
T-fix Sm Introducer
Manufacturer
Smith & Nephew, Inc., Endoscopy DivisionModel number
015181Catalog number
015181
Lot number
UNK
Product problems
- Device, or device fragments remain in patient
- Replace
- Material Separation
- Wire(s), breakage of
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A MENISCORRHAPHY PROCEDURE, THE DELIVERY NEEDLE WAS INSERTED TO SUTURE THE MENISCUS. THE SUTURE CAME OUT WITH THE NEEDLE WHEN THE SURGEON PUSHED OUT THE T-BAR, PULLED OUT THE NEEDLE AND PULLED THE SUTURE TO SEE THAT THE T-BAR WAS FIXED TO THE MENISCUS. T-BAR REMAINS IN THE PT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.