inforMED
MalfunctionNBL

CLEAR-TRAC COMPLETE 5.5MM X 72MM

Received Aug 2, 2006 · Event occurred Mar 20, 2006

Report 1219602-2006-00106 · MDR key 759930

Device

Generic name

*

Model number

7209987

Catalog number

7209987

Lot number

UNK

Product problems

  • Break
  • Tip breakage
  • Device Or Device Fragments Location Unknown

Patient

38 YR

  • Surgery, prolonged
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

SMITH & NEPHEW REPORTED THE 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. THE ARTHROSCOPIC BANKART REPAIR WAS DELAYED 30-MINUTES AS A RESULT. THE SURGEON WAS NOT ABLE TO FIND THE MISSING PIECES IN THE PATIENT. HE FEELS THAT IT MAY HAVE DROPPED ONTO THE FLOOR WHEN RETRIEVING THE CANNULA FROM THE PT'S BODY. THE PT DID NOT HAVE ANY ADVERSE REACTIONS NOR DID HE HAVE TO HAVE A 2ND SURGERY TO REMOVE FOREIGN BODY AND THE PT IS WELL.

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE.