MalfunctionGAS
ULTRA FASTFIX AB ASSEMBLY - CURVED
Received Oct 8, 2009 · Event occurred Sep 9, 2009
Report 1219602-2009-00262 · MDR key 1506956
Device
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
WHEN SURGEON WENT TO PULL OUT THE DEVICE, IT DID NOT RELEASE. T1 WAS LEFT IN THE PT. BOTH T'S WERE DEPLOYED BUT THE SUTURE BROKE, T2 WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FAST-FIX.
Additional Manufacturer Narrative
DEVICE WAS RETURNED FOR EVALUATION. BOTH T'S DEPLOYED, BUT THE SUTURE BROKE. NO CONCLUSION CAN BE DRAWN. (B) (4).