MalfunctionGAS
ULTRA FAST FIX AB ASSEMBLY-CURVED
Received Jun 15, 2009 · Event occurred May 19, 2009
Report 1219602-2009-00179 · MDR key 1471504
Device
Generic name
Ultra Fast Fix Ab Assembly-curved /gat
Manufacturer
Mansfield Manufacturing SiteModel number
72201494Catalog number
72201494
Lot number
50283249
Product problems
- Device, or device fragments remain in patient
- Component Missing
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
DEVICE WILL NOT BE RETURNED FOR EVALUATION. (B) (4).
Description of Event or Problem
DURING A MENISCAL REPAIR, T2 WAS MISSING FROM THE DEVICE, IT WAS CONFIRMED THAT T1 WAS NOT REMOVED FROM THE PT.