OtherKGS
BIO-CORKSCREW SUTURE ANCHOR, W/TWO #2 FIBERWIRE
Received Jul 27, 2004
Report 1220246-2004-00072 · MDR key 536465
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
AR-1920BFCatalog number
AR-1920BF
Lot number
UNK
Product problems
- Material Separation
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DR REPORTED A COMPLICATION AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR WITH BIO-CORKSCREW ANCHOR. DURING THE REVISION SURGERY, THE ANCHOR WAS FULLY SEATED IN BONE AND HAD NOT DISSOCIATED FROM BONE. ON ARTHROSCOPIC VISUALIZATION, THE UNDERSIDE OF THE ROTATOR CUFF, THE ARTHROSCOPIC KNOT TYING WAS SECURE BUT THE INNER SUTURE HAD DISSOCIATED FROM THE ANCHOR. SURGEON HAS ARTHROSCOPIC PICTURES AND HAS RETAINED THE SUTURE AS WELL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION SUCH AS THE LOT NUMBER HAVE BEEN MADE WITHOUT SUCCESS. THIS DEVICE IS USED FOR TREATMENT.
Remedial action
- Other