MalfunctionGAS
ULTRA FAST-FIX AB ASSEMBLY - CURVED
Received Jun 19, 2009 · Event occurred May 21, 2009
Report 1219602-2009-00186 · MDR key 1456487
Device
Generic name
Ultra Fast-fix Ab Assembly - Curved / Gat
Manufacturer
Mansfield Manufacturing SiteModel number
72201494Catalog number
72201494
Lot number
50288880
Product problems
- Positioning Failure
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
- Excessive Tear Production
Narrative
Additional Manufacturer Narrative
DEVICE IS NOT BEING RETURNED FOR EVALUATION.
Description of Event or Problem
AFTER INSERTING THE DELIVERY NEEDLE INTO THE MENISCUS AND ATTEMPTING TO DEPLOY FIRST IMPLANT, THE IMPLANT WOULD NOT FULLY DEPLOY AND BECAME STUCK IN THE MENISCUS. THE MENISCUS TORE AS SURGEON WAS ATTEMPTING TO REMOVE INSERTER NEEDLE AND IMPLANT. THIS WAS THE SECOND ATTEMPT; FIRST ATTEMPT FAILED IN THE SAME MANNER. A THIRD IMPLANT WAS USED AND THE REPAIR WAS COMPLETED.