MalfunctionGAS
FAST-FIX ASSY REVERSE CURVE
Received Sep 21, 2009 · Event occurred Aug 20, 2009
Report 1219602-2009-00249 · MDR key 1504472
Device
Generic name
Fast-fix / Gas
Manufacturer
Mansfield Manufactuing SiteModel number
7209205Catalog number
7209205
Lot number
50151451
Product problems
- Positioning Failure
- Device, or device fragments remain in patient
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
INCORRECTLY ASSEMBLED T1 DEPLOYED, DEVICE PULLED BACK IN PREPARATION OF INSERTING T2. SUTURE FELL OFF T1 LEAVING BAR IN PATIENT NOT ATTACHED TO ANYTHING. REP STATED IT LOOKED LIKE THE KNOT HAD NOT BEEN TIED CORRECTLY.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RECEIVED BY S&N FOR EVALUATION. (B) (4)