MalfunctionGAS
FAST-FIX REVERSE CURVE
Received Jul 20, 2009 · Event occurred Apr 8, 2009
Report 1219602-2009-00209 · MDR key 1483173
Device
Generic name
Fast-fix Reverse Curve / Gas
Manufacturer
Mansfield Manufacturing SiteModel number
7209205Catalog number
7209205
Lot number
50279611
Product problems
- Break
- 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
SUTURE BROKE WHEN THE INSERTER WAS PULLED OUT AFTER T1 WAS DEPLOYED. THERE WAS ALMOST NO RESISTANCE. T1 REMAINS IN THE JOINT.
Additional Manufacturer Narrative
DEVICE WILL NOT BE RETURNED FOR EVALUATION.