inforMED
MalfunctionHTT

CONMED LINVATEC MICRO 100 SMALL BONE SIDECUTTING BUR

Received Feb 2, 2012 · Event occurred Jan 27, 2012

Report 2454074 · MDR key 2454074

Device

Generic name

Sidecutting Burr, Medium Straight

Manufacturer

Con Med

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Break
  • Entrapment of Device
  • Difficult to Remove

Patient

63 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

INTRAOPERATIVELY PHYSICIAN WAS USING A 1.2 X 4.9 MM SIDECUTTING BIT TO DRILL INTO THE PATIENT'S FIRST LEFT LATERAL METATARSAL HEAD WHEN THE BIT FAILED LEAVING SLIGHTLY LESS THAN 1 CM OF THE BIT IN THE PATIENT'S METATARSAL HEAD. ORIGINAL PHYSICIAN WAS ASSISTED BY SECOND PHYSICIAN, WHO BOTH AGREED THAT THE BIT WOULD BE UNRETRIEVABLE DUE TO THE LOCATION WITHOUT CAUSING MORE HARM TO THE PATIENT. THE OUTCOME OF THE SURGERY WAS NOT COMPRIMISED OTHER THAN THE RETAINED BIT. TWO SURGICAL SCREWS WERE PLACED ADJACENT TO THE RETAINED BIT AS PART OF THE PLANNED PROCEDURE. FLUOROSCOPY IMAGES OF THE RETAINED BIT WERE OBTAINED DURING THE PROCEDURE.