inforMED
MalfunctionHTT

MICRO BUR, WIRE PASS, MEDIUM

Received Apr 20, 2012 · Event occurred Apr 4, 2012

Report 2547637 · MDR key 2547637

Device

Generic name

Wire Pass Drill, Medium

Manufacturer

Linvatec Corp,

Model number

*

Catalog number

*

Lot number

315620

Product problems

  • Break

Patient

37 YR

  • Foreign Body In Patient

Narrative

Description of Event or Problem

DURING THE PLANNED PROCEDURE OF RIGHT FOOT ARTHRODESIS OF SECOND METATARSAL JOINT, LEFT FOOT ARTHRODESIS FIRST AND SECOND METATARSAL JOINT, 2 SEPARATE DRILL BITS OF THE SAME TYPE AND LOT NUMBER BROKE OFF AT THE TIP. ONE IN THE SECOND TOE ON RIGHT FOOT, AND ONE ON GREAT TOE ON THE LEFT FOOT. RADIOLOGICAL IMAGES OBTAINED. THE REMAINDER OF THE DRILL BITS WERE RETAINED BY THE MEDICAL CENTER. THE SURGEON NOTIFIED THE PATIENT AND FAMILY OF KNOWN RETAINED FOREIGN BODY. PER THE SURGEON, THE BODIES WERE RETAINED DUE TO THE FACT THAT THEY COULD NOT BE RETRIEVED WITHOUT SIGNIFICANT DAMAGE TO THE BONE. THE OBJECTS ARE NOT EXPECTED TO MIGRATE OR CAUSE FUTURE PROBLEM FOR THE PATIENT.