MalfunctionKGS
T-FIX SMALL INTRODUCER STRAIGHT, SINGLE SUTURE
Received Nov 5, 1999 · Event occurred Oct 4, 1999
Report 1219602-1999-00126 · MDR key 250306
Device
Generic name
Suture Retention Device
Manufacturer
Smith & Nephew, Inc. Endoscopy Div.Model number
NACatalog number
015181
Lot number
381613
Product problems
- Break
- Device, or device fragments remain in patient
- Replace
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Nonresorbable materials, unretrieved in body
- Foreign body, removal of
Narrative
Description of Event or Problem
DEVICE BROKE DURING ATTEMPTED USE IN SURGERY. ONE PIECE WAS RETRIEVED IMMEDIATELY. THE OTHER PIECE WAS NOT FOUND. THE JOINT WAS FLUSHED BUT IT IS UNKNOWN IF THE PIECE FLUSHED OUT. PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. NO PT INJURY WAS REPORTED.