inforMED
MalfunctionGDF

60 DISPOSABLE SUTURE SLIDER WITH NITINOL LOOP (5B

Received Dec 19, 2007 · Event occurred Nov 20, 2007

Report 2936485-2007-00093 · MDR key 972800

Device

Generic name

Suture Slider

Catalog number

3910000101

Lot number

07151AG2

Product problems

  • Break
  • Difficult to Insert

Patient

UNK

  • Surgery, prolonged
  • Foreign body, removal of
  • Surgical procedure, additional

Narrative

Additional Manufacturer Narrative

DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER YET. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION COMPLETED.

Description of Event or Problem

SURGEON INFORMED SALES REPRESENTATIVE THAT THE SUTURE SLIDER GOT BROKEN IN THE SHAFT NEAR THE HANDLE DURING SLAP-OPERATION. SURGEON TOLD SALES REP THAT THE FIRST TIME HE INSERTED THE SUTURE SLIDER, IT CAME OUT 0.5 CM IN WRONG PLACE. SECOND TIME WHEN HE INSERTED THE SUTURE SLIDER INTO THE PATIENT, HE FELT THAT THE SUTURE SLIDER HIT PATIENT'S BONE. WHEN HE PULLED THE SUTURE SLIDER BACK, IT WAS BROKEN. SURGEON TOLD ALSO SALES REP THAT HE USED THE SUTURE SLIDER NORMALLY AND HE DID NOT USE ABNORMAL FORCE OR TORSION. OPEN OPERATION WAS MADE TO GET OUT THE BROKEN PART OF THE SUTURE SLIDER. OPERATION GOT 2 HOURS LONGER THAN NORMAL. THE OPERATION WAS FINISHED AS ARTHROSCOPIC WAY.