inforMED
MalfunctionGFG

DART-FIRE(TM) CANNULATED DRILL BIT

Received Jul 19, 2016 · Event occurred Jun 15, 2016

Report 1043534-2016-00070 · MDR key 5804400

Device

Generic name

Small Joint Instrument

Catalog number

DSDS-0017

Lot number

1261720

Product problems

  • Break

Patient

66 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THIS INCIDENT IS CONSIDERED CLOSED. IF AT ANY TIME NEW OR UPDATED INFORMATION BECOMES AVAILABLE, THE INCIDENT WILL BE RE-OPENED AND INVESTIGATED.

Additional Manufacturer Narrative

THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

ALLEGEDLY, THE TIP OF DRILL BIT 1.7MM CANNULATED WAS BROKEN OFF DURING THE SURGERY. THE PHYSICIAN DECIDED TO LEAVE IT IN THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE AND USED IT TO TIGHTEN THE SCREWS AND COMPLETE THE PROCEDURE.