inforMED
MalfunctionHTW

*

Received Sep 7, 2007 · Event occurred Jul 24, 2007

Report 918129 · MDR key 918129

Device

Generic name

Drill Bit, Orthopedic

Manufacturer

Biomet , Inc.

Model number

1/8 INCH 3.2 MM

Catalog number

32-467619

Lot number

936370

Product problems

  • Break
  • Device, or device fragments remain in patient

Patient

53 YR

  • Nonresorbable materials, unretrieved in body
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

DURING A PATELLOFEMORAL ARTHROPLASTY OF RIGHT KNEE FOR PATELLOFEMORAL ARTHRITIS, THE SURGEON APPLIED AN ANTERIOR CUTTING JIG, HELD IN PLACE WITH 2 PINS. SURGEON HAD SOME DIFFICULTY DRILLING BECAUSE THE PATIENT'S BONE WAS HARD. SURGEON WAS ABLE TO DRILL INTO BONE BUT WHEN HE WAS WITHDRAWING THE BIT AND DRILL FROM THE FEMUR, THE BIT BROKE, LEAVING A 1 INCH PIECE OF DRILL BIT BURIED IN THE FEMUR. THE ANTERIOR ASPECT OF THE FEMUR WAS TRANSECTED AND THEN THE OTHER PIN WAS REMOVED. THE SURGEON EXAMINED THE PIN SITE IN THE FEMUR AND FELT THAT THE SMALL PIECE OF PIN THAT WAS BROKEN OFF IN THE BONE WOULD BE BEST LEFT IN PLACE TO PREVENT RISK OF INJURY FROM REMOVING THE BIT WITH AN OSTEOTOME AND MAKING A LARGE HOLE IN THE FEMUR. THE ANTERIOR SURFACE WAS AGAIN SIZED FOR A SMALL FEMUR AND THE PROCEDURE WAS COMPLETED WITH GOOD ALIGNMENT. X-RAY TAKEN POST-OP SHOWS THE METALLIC POST-OP THREADED PIN WITHIN THE MEDULLARY SHAFT OF THE DISTAL FEMUR. PATIENT HAD AN UNCOMPLICATED POST-OP COURSE AND WENT HOME ON POST-OP DAY THREE. THE REMAINING PIECE OF THE DRILL BIT WAS SAVED AND IS STORED AT THE HOSPITAL.