MalfunctionGAS
ULTRA FASTFIX AB ASSEMBLY - CURVED
Received Oct 23, 2009 · Event occurred Sep 23, 2009
Report 1219602-2009-00272 · MDR key 1518017
Device
Generic name
Ultra Fastfix Ab Assembly - Curved/gat
Manufacturer
Mansfield Manufacturing SiteModel number
72201494Catalog number
72201494
Product problems
- Use of Device Problem
- Device Issue
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
WHEN THE SURGEON WAS USING THE FASTFIX ANCHOR, T1 AND T2 DEPLOYED AT THE SAME TIME. THE SALES REPRESENTATIVE SPOKE TO THE SURGEON AND HE THINKS HE MAY BE ACCIDENTALLY ADVANCING THE GOLD THUMB BUTTON AS HE IS INSERTING T1 INTO MENISCUS. T1 REMAINS IN THE PATIENT UNSUPPORTED.
Additional Manufacturer Narrative
DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.