inforMED
InjuryGFG

NON STERILE DRILL BIT

Received Nov 24, 2015 · Event occurred Jul 1, 2014

Report 1043534-2015-00108 · MDR key 5246944

Device

Generic name

Unk

Catalog number

AP02-010

Lot number

M425EOS

Product problems

  • Break

Patient

Not reported

  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

THIS IS A RETROSPECTIVE REPORT AFTER THE ACQUISITION OF BIOTECH INTERNATIONAL. EVALUATION WAS PERFORMED BY BIOTECH INTERNATIONAL. BECAUSE THE DRILL BIT IS VERY OLD, WEAR AND TEAR IS PROBABLY THE CAUSE OF THE BREAKAGE.

Description of Event or Problem

THE END OF THE DRILL BIT BROKE DURING THE OPERATION AND PIECES REMAINED IN THE PATIENT.