MalfunctionKGS
KINSA SUTURE ANCHOR SYSTEM
Received Apr 10, 2008
Report 1219602-2008-00101 · MDR key 1028284
Device
Generic name
Kinsa
Manufacturer
Smith & Nephew Inc., Endoscopy Div.Model number
72200239Catalog number
72200239
Lot number
UNK
Product problems
- Difficult to Insert
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ONCE THE ANCHOR WAS INSERTED INTO THE HOLE, WHEN TRYING TO REDUCE THE KNOT, THE KNOT WOULD NOT SLIDE. THE DEVICE WAS ABANDONED AND DRILLED OUT. THE SURGEON USED A COMPETITORS DEVICE TO FINISH THE SURGERY. THERE WAS NO PT INJURY NOTED.
Additional Manufacturer Narrative
NO PRODUCT IS BEING RETURNED FOR EVALUATION.