inforMED
MalfunctionNEW

QUILL MONODERM

Received Dec 19, 2016 · Event occurred Oct 2, 2016

Report 6185000 · MDR key 6185000

Device

Generic name

Suture, Surgical

Catalog number

YA-2021Q

Lot number

MQ28910

Product problems

  • Failure To Adhere Or Bond
  • Material Frayed

Patient

22 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PHYSICIAN WAS USING A QUILL SUTURE TO CLOSE AN INCISION DURING A TRAUMA CASE. THE DOCTOR STATED THAT THE SUTURE WAS NOT GRASPING THE TISSUE AND THAT THE FIBERS WERE FRAYING. A SECOND QUILL SUTURE WAS OPENED AND THE SAME PROBLEM OCCURRED. A THIRD QUILL WAS USED TO COMPLETE THE PROCEDURE. BOTH OF THE MALFUNCTIONING QUILL SUTURES WERE SAVED AND WILL BE RETURNED TO THE MANUFACTURER.