MalfunctionGAS
ULTRA FAST-FIX AB ASSEMBLY - CURVED
Received Aug 19, 2009 · Event occurred Jul 16, 2009
Report 1219602-2009-00230 · MDR key 1493597
Device
Generic name
Ultra Fast-fix Ab Assembly - Curved / Gat
Manufacturer
Mansfield Manufacturing SiteModel number
72201494Catalog number
72201494
Lot number
50295772
Product problems
- Positioning Failure
Patient
Not reported
- Excessive Tear Production
Narrative
Additional Manufacturer Narrative
DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B) (4).
Description of Event or Problem
THE SURGEON COULD NOT DEPLOY T1 ONE TWO DEVICES, AS A RESULT, THE MENISCUS WAS DAMAGED. THE SURGEON USED A COMPETITOR'S DEVICE, BUT WAS UNHAPPY WITH THE REPAIR, SO HE WENT BACK TO FAST-FIX TO COMPLETE THE REPAIR.