MalfunctionKGS
T-FIX SM INTRODUCER CURVED, SINGLE SUT
Received Apr 29, 1999 · Event occurred Nov 19, 1998
Report 1219602-1999-00030 · MDR key 221737
Device
Generic name
T-fix Sm Introducer
Manufacturer
Smith & Nephew, Inc. Endoscopy DivisModel number
NACatalog number
015182
Lot number
004292
Product problems
- Break
- Replace
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
T-FIX SUTURE BAR BROKE WHILE IN USE IN SURGERY. NO PT INJURY OR COMPLICATION OCCURRED. CONTACT STATED THAT BROKEN T-FIX WAS PULLED FREE AND ANOTHER WAS USED. IT IS UNK WHETHER BROKEN FRAGMENT WAS LEFT IN THE BODY OR RETRIEVED.