inforMED
MalfunctionNBL

CLEAR-TRAC COMPLETE 5.5MM X 72MM

Received Aug 10, 2006 · Event occurred Mar 20, 2006

Report 1219602-2006-00115 · MDR key 773688

Device

Generic name

Search Of Records Shows

Model number

7209987

Catalog number

7209987

Lot number

UNK

Product problems

  • Break
  • Component(s), broken
  • Replace
  • Tip breakage

Patient

38 YR

  • Surgery, prolonged
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A PIECE DID BREAK OFF INSIDE BODY OF PT AND THEY WERE ABLE TO REMOVE MOST OF IT. SURGEON INTRODUCED THE DISPOSABLE CANNULA, PUSHING THE CANNULA INTO THE SHOULDER JOINT. WHEN THE CANNULA WAS IN PLACE, HE REMOVED THE GUIDING ROD FROM THE POSTERIOR PORTAL AND RE-INSERTED THE TELESCOPE TO CARRY ON WITH THE PROCEDURE. IT WAS THEN DISCOVERED THAT, THE TIP PORTION OF THE DISPOSABLE WAS BROKEN. A DELAY OF THIRTY MINUTES RESULTED. BACK-UP DEVICES WERE AVAILABLE.

Additional Manufacturer Narrative

EVALUATION OF THE DEVICE SHOWED THE DISTAL END OF THE CANNULA IS BROKEN AND SMALL PIECES ARE MISSING. CONDITION OF THE DEVICE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED HOWEVER, A CONCLUSION COULD NOT BE MADE FOR THE REPORTED FAILURE.