inforMED
MalfunctionKGS

F-FIX SM INTRODUCER STRAIGHT SINGLE SUT

Received Jan 16, 2002 · Event occurred Dec 4, 2001

Report 1219602-2002-00010 · MDR key 373445

Device

Generic name

F-fix Sm Introducer

Model number

NA

Catalog number

015181

Lot number

390064

Product problems

  • Break
  • Device, or device fragments remain in patient

Patient

UNKNOWN

  • Nonresorbable materials, unretrieved in body
  • Surgical procedure, delayed

Narrative

Description of Event or Problem

THE SURGEON WAS PERFORMING A PROCEDURE WHEN THE SUTURE COMPONENT OF A T-FIX DEVICE BROKE. WHEN THE SUTURE BROKE THE T PORTION, WHICH IS SUSPENDED BY THE SUTURE, FELL INTO THE PATIENT. THE SURGEON WAS NOT ABLE TO RETRIEVE THE T FROM THE PATIENT. AS A RESULT, THE BROKEN SUTURE CAUSED A 20 MINUTE DELAY. THERE WAS NO PATIENT INJURY OR PROCEDURAL COMPLICATION REPORTED.