inforMED
MalfunctionKGS

KINSA SUTURE ANCHOR SYSTEM

Received May 16, 2008

Report 1219602-2008-00129 · MDR key 1046732

Device

Generic name

Kinsa

Model number

72200239

Catalog number

72200239

Lot number

50217113

Product problems

  • Break
  • Device, or device fragments remain in patient

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THREE ANCHORS WERE USED. SUTURES BROKE AND 2 ANCHORS REMAIN IN THE PT, THE THIRD ANCHOR WAS ABLE TO SECURE THE ANCHOR. THE PROCEDURE EXPERIENCED A 30 MINUTES DELAY AND A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE REPAIR. THERE WAS NO PT INJURY REPORTED AND NO ADDITIONAL INFO AVAILABLE AT THIS TIME.