MalfunctionKGS
T-FIX SUTURE BAR
Received Jun 27, 2001 · Event occurred May 29, 2001
Report 1219602-2001-00057 · MDR key 340517
Device
Generic name
Suture Retention Device
Manufacturer
Smith & Nephew, Inc. Endoscopy DivModel number
NACatalog number
015181
Lot number
410168
Product problems
- Break
- Difficult to Insert
- Replace
Patient
UNKNOWN
- Surgery, prolonged
Narrative
Description of Event or Problem
SIXTEEN T-FIX SUTURE BAR IMPLANTS BROKE DURING INSERTION. TWO IMPLANTS WERE NOT REMOVED. SURGERY TIME WAS EXTENDED APPROX 2 HOURS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE PRODUCT.